BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOXCROSS PTA CATHETER

    MDR report key: 1706601 · Received May 18, 2010

    Report

    Report Number
    9710478-2010-00071
    Event Type
    Malfunction
    Date Received
    May 18, 2010
    Date of Event
    April 22, 2010
    Report Date
    April 23, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    LIT
    PMA / PMN Number
    K081417
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE DEVICE HAS BEEN RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. THE 7 X 20 MM FOXCROSS (PART 10316-20, LOT 614192), AND THE 7 X 30 MM FOXCROSS (PART 10316-30, LOT 534583), INDICATED, ARE BEING FILED UNDER SEPARATE MFR #'S.

    Description of Event or Problem · 1

    DEVICE ISSUE: BALLOON RUPTURE. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT IN A MODERATELY CALCIFIED LESION IN THE ILIAC ARTERY AFTER IMPLANTATION OF AN ABSOLUTE PRO STENT, POST-DILATATION WAS ATTEMPTED WITH 3 FOX CROSS BALLOONS. ALL 3 BALLOONS RUPTURED AT 10-12 ATMOSPHERES. AN OMNILINK ELITE WAS PLACED INSIDE THE ABSOLUTE PRO. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOXCROSS PTA CATHETER LIT ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 591485

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SHEATH: CROSSOVER 7F. FA. COOK| CATHETER: 7 X 20 MM FOXCROSS| (PART 10316-30, LOT 534583)| STENT: ABSOLUTE PRO 8.0 X 40MM| OMNILINK ELITE 7.0 X29| (PART 10316-20, LOT 614192)| 7 X 30 MM FOXCROSS