BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    MDR report key: 1053260 · Received May 28, 2008

    Report

    Report Number
    3005099803-2008-00563
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Report Date
    April 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THAT A ZERO TIP NITINOL STONE RETRIEVAL BASKET (PATIENT AGE, SEX, WEIGHT UNKNOWN) WAS BEING PREPARED FOR USE IN A PROCEDURE (DATE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS FOUND THE TIP OF WIRE HAD A CRACK. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO TIP NITINOL STONE RETRIEVAL BASKET FFL BOSTON SCIENTIFIC CORPORATION M0063901010 11172730

    Patients

    Seq Age Sex Outcome Treatment
    1