BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILTRAC .035 PERIPHERAL DILATATION CATHETER

    MDR report key: 1032161 · Received April 18, 2008

    Report

    Report Number
    3004742046-2008-00085
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 21, 2008
    Report Date
    March 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 Location
    AA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: THE RETURNED BALLOON WAS LOOSELY FOLDED. A PINHOLE RUPTURE WAS OBSERVED ON THE BALLOON 1.5 MM DISTAL TO THE PROXIMAL SHOULDER WHEN THE BALLOON WAS INFLATED TO 4 ATM. SCRATCHES WERE OBSERVED AROUND THE PINHOLE. SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS OF THE RETURNED DEVICE FOUND MECHANICAL DAMAGE (PINHOLE AND SCRATCHES) TO THE OUTER SURFACE OF THE BALLOON. THE SPECIFIC ROOT CAUSE FOR THE MECHANICAL DAMAGE OBSERVED ON THE BALLOON COULD NOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT FOUND NO NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: BALLOON RUPTURE. TIME OF MALFUNCTION: DURING PRE-DILATATION. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING PRE-DILATATION OF A CALCIFIED LESION IN THE ILIAC ARTERY, THE AGILTRAC BALLOON RUPTURED BELOW NOMINAL PRESSURE. THE BALLOON AND DELIVERY SYSTEM WERE REMOVED AND THE CASE WAS COMPLETED USING AN UNSPECIFIED PRODUCT. THERE WAS NO ADVERSE PT EFFECT. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILTRAC .035 PERIPHERAL DILATATION CATHETER LIT ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 8010751

    Patients

    Seq Age Sex Outcome Treatment
    1