Form Filled By:*
Reporter Email:*
Subject:*
Product (lot, batch, document) or service involved:*
Date of event:*
Physician Name:*
Facility Name:*
Country:* —Please choose an option—USADenmarkEstoniaFinlandFranceGermanyGreeceHungaryIrelandItalyLatviaLithuaniaLuxembourgMaltaNetherlandsPolandPortugalRomaniaSlovakiaSloveniaSpainSwedenIsraelBrazilArgentinaTurkeyMexico
How many times have you experienced the cause for this complaint (1 - 10)?
BYCROSS Model:* —Please choose an option—507095130
Is the complaint related to an issue that occurred prior to the use of the device, during its operation or afterwards?* —Please choose an option—Prior to useDuring useAfter use
[group isDuring clear_on_hide]
Treated Vessel (use Ctrl key to select multiple items):* IliacCFASFAProfundaPoplitealBTK >= 2mmAV FistulaNative VesselBypassBypass GraftStentOther
[group treatedVesselOther clear_on_hide] Please provide more information: [/group]
Lesion Type*: —Please choose an option—ThromboembolicAtherosclerotic
[group atheroscleroticType clear_on_hide] PACCS (0-4): [/group]
Lesion Duration and Progress (use Ctrl key to select multiple items): AcuteSubacuteChronic
[group acuteType clear_on_hide] Acute Type: —Please choose an option—TASC ITASC lIaTASC lIbTASC III [/group]
[group chronicType clear_on_hide] Rutherford (0-6): [/group]
Lesion Location (use Ctrl key to select multiple items): ProximalMedialDistal
[group typeOther clear_on_hide] Please provide more information: [/group]
Lesion Diameter (mm):*
Lesion Length (mm):*
Lesion Stenosis (%) pre procedure:*
Vessel internal diameter (mm):*
Guide Wire Name:
Guide Wire Manufacturer:
Guide Wire Type*: —Please choose an option—StiffExtra-StiffHydrophilicOther
[group guideWireTypeOther clear_on_hide] Please provide more information: [/group]
Guide Wire Size*: —Please choose an option—0.035'0.018'0.014'Other
[group guideWireOther clear_on_hide] Please provide more information: [/group]
Was an introducer used: —Please choose an option—YesNo
[group introducerUsed clear_on_hide] Introducer Name:
Introducer Manufacturer:
Introducer Size (3F-9F):
Introducer Length (cm): [/group]
Was a sheath used: —Please choose an option—YesNo
[group sheathUsed clear_on_hide] Sheath Name:
Sheath Manufacturer:
Sheath Size (3F-9F):
Sheath Length (cm): [/group]
Approach:* —Please choose an option—AntegradeCrossoverRetrogradeOther
[group approachOther clear_on_hide] Please provide more information: [/group]
Initial Passage:* —Please choose an option—With guide wirewithout guide wire
Lesion Stenosis (%) post procedure:*
Adjunctive Therapy:* —Please choose an option—NonePTA OnlyStent OnlyPTA + StentOther
[group adjunctiveOther clear_on_hide] Please provide more information: [/group]
[/group]
Complaint Classification:* —Please choose an option—Alleged to be associated with death or life-threatening injuryHas the potential of causing death or life-threatening injuryAlleged to be associated with non-life-threatening injuryHas the potential of causing non-life-threatening injuryIntended use not met due to technical failureIntended use met but with technical difficultyAdministrative Error
[group compliantClassificationRemark clear_on_hide] Please keep the device, not washed and not decontaminated, after removal of the batteries according to the IFU for investigation. [/group]
Did you complete the procedure with the device related to this complaint, or did you use a second device?* —Please choose an option—Completed with one deviceUsed a second deviceOther
[group didYouOther clear_on_hide] Please provide more information: [/group]
Complaint Category: —Please choose an option—Air in the collection bagElectricIteration of BYCROSS with other equipmentTechnicalContrast injectionBreak of componentLabelling
[group electricError clear_on_hide] Electric Error (use Ctrl key to select multiple items):* —Please choose an option—Constant Green light but no rotationConstant Red light during test before usageConstant Red light during use at speed 1Constant Red light during use at speed 2Blinking Red light during use at speed 1Blinking Red light during use at speed 2No rotation at LOW but Rotating at HIGHNo rotation at HIGH but Rotating at LOWNo rotation reverse [/group]
[group otherEquipment clear_on_hide] Other Equipment:* —Please choose an option—With the guide wireWith introducer [group withTheGuideWire clear_on_hide] Guide Wire Issues:* —Please choose an option—Guide wire stuck inside the BYCROSSGuide wire cannot be inserted into the BYCROSSBYCROSS tip caught in stent [/group] [group withTheIntroducer clear_on_hide] Introducer Issues:* —Please choose an option—BYCROSS damaged the introducerBYCROSS could not be removed out of the introducer [/group] [/group]
[group technical clear_on_hide] Technical:* —Please choose an option—Wing not openWing not closedMotor run but no rotationFeeding guidewire not possibleOther [/group]
[group contrastInjection clear_on_hide] Contrast Injection:* —Please choose an option—Leak out of the handlePoor visualizationInjection not possible [/group]
[group breakOfComponent clear_on_hide] Break of component:* —Please choose an option—WingShaftHandlePackagePull tabCollection bag [/group]
[group labelling clear_on_hide] Labelling:* —Please choose an option—IFU Missing in the packageWrong labelMissing labelUnclear label [/group]
Was this complaint reported to additional entity?* —Please choose an option—This complaint was NOT reportedFDACompetent Authority (via EUDAMED, if applicable)Notify bodyEU authorized representativeDistributerOther
[group reportedToOther clear_on_hide] Please provide more information: [/group]
Describe the reason for the complaint:*
Consequences or effects of the reported defect, deficiency, or other phenomenon:
If you have a recommendation for corrective action, please share it with us:
Add images (in JPEG or PNG format):
