BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX PLUS PTA CATHETER

    MDR report key: 1890295 · Received October 22, 2010

    Report

    Report Number
    9710478-2010-00134
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ABBOTT VASCULAR-BERINGEN
    Product Code
    LIT
    PMA / PMN Number
    K081417
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED COMPLETE FOR INVESTIGATION. THE DEVICE DID NOT SHOW ANY KINKS OR OTHER DAMAGE. THE BALLOON WAS RECEIVED NOT FOLDED. THE SOFT TIP WAS OBSERVED AND IT WAS CONSIDERED TO BE CONFORMING. ALSO THE DISTAL AND PROXIMAL BALLOON END AND MARKER DID NOT SHOW ANY ABNORMALITIES. THE GUIDEWIRE LUMEN WAS FLUSHABLE AND THE 0.035 GUIDE WIRE COMPATIBILITY WAS PERFORMED SUCCESSFULLY. THE INFLATION OF THE BALLOON COULD NOT BE PERFORMED BECAUSE OF THE MATERIAL RUPTURE. THE DEVICE SHOWED A PINHOLE MATERIAL RUPTURE AT DISTAL END OF BALLOON. IT IS LIKELY THAT THE FAILURE DEVELOPED DURING USE IN A HEAVILY CALCIFIED LESION. ACCORDING TO THIS INVESTIGATION NO EVIDENCE COULD BE FOUND WHICH SUPPORTS THE ASSUMPTION THAT A DEVICE DEFECT LED TO PROBLEMS DESCRIBED IN THE CASE DESCRIPTION. A REVIEW OF THE LOT HISTORY RECORD FOR THIS DEVICE DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT YET COMPLETE. THE 5.0 X 40 FOX PLUS (PART AP14005, LOT 620593), INDICATED IS BEING FILED UNDER A SEPARATE MFR #.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE OF THE HEAVILY CALCIFIED MID SUPERFICIAL FEMORAL ARTERY (SFA) USING AN ANTEGRADE PUNCTURE AT THE COMMON FEMORAL ARTERY, THE FOX PLUS BALLOON CATHETER WAS ADVANCED TO THE MIDDLE SEGMENT OF THE SUPERFICIAL FEMORAL ARTERY OVER THE 5 FR INTRODUCER SHEATH, BUT THE BALLOON RUPTURED BEING INFLATED AT 8-10 ATMOSPHERES (ATM). A SECOND FOX PLUS WAS ATTEMPTED AND DURING THE INFLATION ATTEMPT THE BALLOON RUPTURED AT 8-10 ATM. BOTH BALLOONS WERE INFLATED USING A SYRINGE. ALL PIECES OF BOTH BALLOONS COULD BE REMOVED FROM THE ANATOMY WITHOUT DIFFICULTY; NOTHING REMAINED IN THE PATIENT ANATOMY. THERE WAS NO REPORTED PATIENT SEQUELA. NO ADD'L INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED DURING PREPARATION OF THE DEVICE HE NOTED THE POLYGLYCOLICLACTIC ACID (PGLA) SUTURE ON THE COIL HAD PREMATURELY DEGRADED. THERE WERE CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOX PLUS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT ABBOTT VASCULAR-BERINGEN NA 626288

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR (PART AP14005, LOT 620593)| GUIDE WIRE: V18| STENT: OPTIMED 418| SHEATH: TERUMO 5FR| DILATATION CATHETER: 5.0 X 40 FOX PLUS