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
Treated Vessel (use Ctrl key to select multiple items):* IliacCFASFAProfundaPoplitealBTK >= 2mmAV FistulaNative VesselBypassBypass GraftStentOther
Please provide more information:
Lesion Type*: —Please choose an option—ThromboembolicAtherosclerotic
PACCS (0-4):
Lesion Duration and Progress (use Ctrl key to select multiple items): AcuteSubacuteChronic
Acute Type: —Please choose an option—TASC ITASC lIaTASC lIbTASC III
Rutherford (0-6):
Lesion Location (use Ctrl key to select multiple items): ProximalMedialDistal
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
Guide Wire Size*: —Please choose an option—0.035'0.018'0.014'Other
Was an introducer used: —Please choose an option—YesNo
Introducer Name:
Introducer Manufacturer:
Introducer Size (3F-9F):
Introducer Length (cm):
Was a sheath used: —Please choose an option—YesNo
Sheath Name:
Sheath Manufacturer:
Sheath Size (3F-9F):
Sheath Length (cm):
Approach:* —Please choose an option—AntegradeCrossoverRetrogradeOther
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
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
Please keep the device, not washed and not decontaminated, after removal of the batteries according to the IFU for investigation.
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
Complaint Category: —Please choose an option—Air in the collection bagElectricIteration of BYCROSS with other equipmentTechnicalContrast injectionBreak of componentLabelling
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
Other Equipment:* —Please choose an option—With the guide wireWith introducer
Guide Wire Issues:* —Please choose an option—Guide wire stuck inside the BYCROSSGuide wire cannot be inserted into the BYCROSSBYCROSS tip caught in stent
Introducer Issues:* —Please choose an option—BYCROSS damaged the introducerBYCROSS could not be removed out of the introducer
Technical:* —Please choose an option—Wing not openWing not closedMotor run but no rotationFeeding guidewire not possibleOther
Contrast Injection:* —Please choose an option—Leak out of the handlePoor visualizationInjection not possible
Break of component:* —Please choose an option—WingShaftHandlePackagePull tabCollection bag
Labelling:* —Please choose an option—IFU Missing in the packageWrong labelMissing labelUnclear label
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
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):
