BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER RX BALLOON DILATATION CATHETER

    MDR report key: 1963852 · Received December 22, 2010

    Report

    Report Number
    2953200-2010-02612
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION, RESULTS/CONCLUSIONS - (80% STENOSIS). EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION. HARDENED BLOOD RESIDUE AND A CRYSTALLIZED SUBSTANCE WERE PRESENT INSIDE THE INFLATION LUMEN AND BALLOON. THE BALLOON AND DISTAL TIP WERE FLATTENED. INFLATION TO NOMINAL PRESSURE WAS UNSUCCESSFUL DUE TO DRIED BLOOD PRESENT WITHIN THE INFLATION. A LARGE HOLE DUE TO TORN BALLOON MATERIAL WAS LOCATED DIRECTLY OVER THE INNER SHAFT MARKER BAND. THE HOLE COMMENCED ON THE PROXIMAL SIDE OF THE MARKER. BUNCHING WAS EVIDENT ON THE DISTAL SIDE OF THE BALLOON TEAR.

    Description of Event or Problem · 1

    A SPRINTER RX BALLOON DILATATION CATHETER, LENGTH 15 MM, DIAMETER 1.5 MM, WAS INTENDED TO TREAT AN 80% STENOSED LESION IN A PATIENT. IT WAS REPORTED THAT THE BALLOON BURST AT 11PA. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ABNORMALITIES NOTED. IT WAS REPORTED THAT PRESSURE WAS RAMPED UP RAPIDLY. A LITTLE RESISTANCE WAS NOTED DURING DELIVERY OF THE DEVICE TO LESION. A STENT WAS USED TO TREAT THE LESION. THE PATIENT WAS WELL POST PROCEDURE AND NO CLINICAL SEQUELAE HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINTER RX BALLOON DILATATION CATHETER LOX MEDTRONIC CARDIOVASCULAR GALWAY NA 0001139007

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK