BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILTRAC .035 PERIPHERAL DILATATION CATHETER

    MDR report key: 1084432 · Received July 29, 2008

    Report

    Report Number
    3004742046-2008-00180
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 8, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    LIT
    PMA / PMN Number
    K062843
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE #: AGILTRAC DILATATION CATHETER .035 PART 1010061-100, LOT 7072551 REFERENCED IS FILED UNDER MFR# 3004742046-2008-00179. EVALUATION SUMMARY: THE BALLOON CATHETER WAS RETURNED WITH THE BALLOON TIGHTLY FOLDED. THERE WAS A TEAR IN THE BALLOON AT THE PROXIMAL END OF THE PROXIMAL MARKER. THERE WAS A CONTINUOUS SCRATCH ON THE SHAFT BEGINNING ON THE TIP. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. THE DEVICE HAD A DEEP GOUGE AND SCRATCHES EXTENDING FROM THE DISTAL TIP OF THE CATHETER TO THE TORN BALLOON MATERIAL, LOCATED IN THE PROXIMAL TAPER, PROXIMAL OF THE PROXIMAL BALLOON MARKER. THIS TYPE OF LONGITUDINAL GOUGE LEADING UP TO THE TEAR HAS NOT BEEN OBSERVED DURING MANUFACTURING. THE DAMAGE OBSERVED COULD BE CAUSED BY ANOTHER DEVICE, SUCH AS GUIDING CATHETER WITH A ROUGH EDGE. NO MANUFACTURING ISSUES WERE DETECTED. A CONCLUSIVE ROOT CAUSE FOR THE TORN BALLOON MATERIAL AND GOUGE COULD NOT BE DETERMINED. REVIEW OF THE LOT HISTORY RECORD SHOWED NO ON-CONFORMITIES AND A QUERY OF THE OVER THE WIRE AGILTRAC .035" DATA BASE SHOWED NO SIMILAR COMPLAINTS. THE TEST DATA FROM THE LOT HISTORY RECORD FOR RELIABILITY ENGINEERING ON-LINE SHOWED THAT THE TESTED SAMPLES FAR EXCEEDED THE PROD SPECIFICATION. ALL OVER THE WIRE AGILTRAC .035" BALLOON CATHETERS ARE 100% VISUALLY INSPECTED FOR SHAFT DAMAGE AND BALLOON DAMAGE, AND 100% BALLOON DIMENSIONAL AND LEAK TESTING.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DEVICE #2, BALLOON RUPTURE. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, THE AGILTRAC DILATATION CATHETER (PART 1010061-100) WAS ADVANCED WITHOUT SIGNIFICANT RESISTANCE. DURING LESION PRE-DILATATION, THE BALLOON RUPTURED AT 4 ATMOSPHERES, BELOW RATED BURST PRESSURE. THE BALLOON AND DELIVERY SYSTEM WERE COMPLETELY REMOVED UNEVENTFULLY. LESION DILATATION WAS COMPLETED USING A NON-ABBOTT BALLOON. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. A SECOND AGILTRAC (PART 1010060-100) WAS ADVANCED TO THE TARGET LESION AFTER DEVICE PREPARATION WAS DONE AND ALL AIR WAS REMOVED BY PULLING NEGATIVE PRESSURE ON THE BALLOON. THE INFLATION DEVICE WAS ATTACHED AND THE PHYSICIAN IMMEDIATELY OBSERVED AIR BUBBLES IN THE ROTATING HEMOSTATIC VALVE AND CONNECTIVE TUBING. THE DEVICE WAS COMPLETELY REMOVED AND A BALLOON PINHOLE WAS CONFIRMED. LESION DILATATION WAS DONE USING A NON-ABBOTT BALLOON. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILTRAC .035 PERIPHERAL DILATATION CATHETER LIT ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 6082851

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PART 1010061-100| AGILTRAC DILATATION CATHETER .035| LOT 7072551 (PART #1)