BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    MDR report key: 1983732 · Received February 10, 2011

    Report

    Report Number
    3005099803-2011-00348
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE DEVICE BASKET WAS DETACHED AND BASKET WIRE WAS BROKEN. THE BASKET AND ALL BASKET WIRES WERE PRESENT AND ATTACHED. BASED ON THE ANALYSIS, IT WAS DETERMINED THAT THE BASKET WOULD NOT OPEN DUE TO THE OUTER SHEATH BEING TORN, STRETCHED AND KINKED. KINKS WERE ALSO FOUND ON THE DRIVE WIRE AND HANDLE CANNULA. RESIDUE WAS PRESENT ON THE DEVICE WHEN RETURNED, AND THE DEFECTS IDENTIFIED DURING THE INVESTIGATION WERE CONSISTENT WITH THOSE CAUSED DURING USE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL/PHYSIOLOGICAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP NITINOL RETRIEVAL BASKET WAS OPENED FOR USE IN A URS PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION FOR THE PROCEDURE, IT WAS NOTED THAT THE BASKET WIRE DETACHED. THE PATIENT WAS REPORTED TO BE IN "GOOD/STABLE" CONDITION AT THE CONCLUSION OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP NITINOL RETRIEVAL BASKET WAS OPENED FOR USE IN A URS PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION FOR THE PROCEDURE, IT WAS NOTED THAT THE BASKET WIRE DETACHED. THE PATIENT WAS REPORTED TO BE IN "GOOD/STABLE" CONDITION AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO TIP NITINOL STONE RETRIEVAL BASKET DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063901030 13967961

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR