BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOX PLUS PTA CATHETER

    MDR report key: 1111726 · Received August 11, 2008

    Report

    Report Number
    9710478-2008-00092
    Event Type
    Injury
    Date Received
    August 11, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 18, 2008
    Manufacturer
    ABBOTT VASCULAR SWITZERLAND
    Product Code
    LIT
    PMA / PMN Number
    K062843
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICE WAS RETURNED INCOMPLETE FOR INVESTIGATION. THE TIP, ONE MARKER, AND ONE QUARTER OF THE BALLOON WERE MISSING. ONE MARKER WAS DISLOCATED AND LOOSE. THE DEVICE SHOWED A KINK. THE BALLOON WAS CUT. FLUSHING OF THE DEVICE WAS POSSIBLE. THE 0.035" GUIDE WIRE COULD BE INSERTED FROM THE DISTAL AS WELL AS FROM THE PROXIMAL SIDE OF THE DEVICE WITHOUT ANY ABNORMALITIES. SLIGHT RESISTANCE WAS FELT AT THE KINK, BUT GUIDE WIRE COMPATIBILITY WAS FOUND. A ROOT CAUSE FOR THE BALLOON RUPTURE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION. NO MANUFACTURING ISSUE WAS DETECTED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITY WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: BALLOON RUPTURE. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: DETACHED BALLOON FRAGMENT AND FISTULA THROMBUS SURGICALLY REMOVED. IT WAS REPORTED THAT DURING A FISTULA ANGIOPLASTY PROCEDURE, THE FOX PLUS BALLOON RUPTURED AT AN UNSPECIFIED PRESSURE, DURING THE THIRD OR FOURTH INFLATION. THE DELIVERY CATHETER WAS REMOVED BUT A DETACHED BALLOON FRAGMENT REMAINED IN THE PT'S ANATOMY. THE PT UNDERWENT SURGICAL REMOVAL OF A FISTULA THROMBUS AND THE DETACHED BALLOON FRAGMENT. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOX PLUS PTA CATHETER LIT ABBOTT VASCULAR SWITZERLAND NA 522960

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention