BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX PLUS PTA CATHETER

    MDR report key: 1202214 · Received October 16, 2008

    Report

    Report Number
    9710478-2008-00142
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 26, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. WITHOUT THE DEVICE TO EXAMINE, NO DETERMINATION CAN BE MADE AS TO THE ROOT CAUSE OF THE REPORTED EVENT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITY WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT. THE FOX PLUS PTA CATHETER PART# AP14005, LOT# 546298 REFERENCED IS BEING FILED UNDER MFR REPORT NUMBER.

    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 A RIGHT SUPERFICIAL FEMORAL ARTERY ANGIOPLASTY, IN A HEAVILY CALCIFIED VESSEL, TWO BALLOONS RUPTURED. THE FIRST BALLOON RUPTURED ON THE SECOND INFLATION AT NO MORE THAN 12 ATM. THE SECOND BALLOON RUPTURED ON THE FIRST INFLATION ALSO AT NO MORE THAN 12 ATM. THERE WERE NO ADVERSE PT EFFECTS REPORTED. ALTHOUGH REQUESTED, THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOX PLUS PTA CATHETER LIT ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 546298

    Patients

    Seq Age Sex Outcome Treatment
    1 DEVICE #1: FOX PLUS PART# AP14005