BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX SV PTA CATHETER

    MDR report key: 1161551 · Received September 15, 2008

    Report

    Report Number
    9710478-2008-00117
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 27, 2008
    Manufacturer
    ABBOTT VASCULAR SWITZERLAND
    Product Code
    LIT
    PMA / PMN Number
    K062843
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. THE FIRST FOX SV PTA CATHETER (LOT UNK) IS FILED UNDER MFR# 9710478-2008-00116.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: BALLOON RUPTURE. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE IN THE POPLITEAL AND PERONEAL ARTERIES FOR UNSPECIFIED IN-STENT RESTENOSIS, THE FOX SV WAS ADVANCED TO THE TARGET LESION. WHEN THE PHYSICIAN PULLED NEGATIVE, BLOOD ENTERED THE CATHETER SHAFT. THE DEVICE WAS COMPLETELY REMOVED AND A SECOND FOX SV WAS USED WITH THE SAME RESULT. AFTER REMOVAL FROM THE BODY BOTH DEVICES WERE INSPECTED AND PINHOLES WERE OBSERVED IN BOTH BALLOONS. THE PINHOLES WERE NOT OBSERVED DURING DEVICE PREPARATION. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DEVICE #1: FOX SV PTA CATHETER| (LOT UNK)