BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    MDR report key: 821119 · Received January 19, 2007

    Report

    Report Number
    6000043-2007-00007
    Event Type
    Malfunction
    Date Received
    January 19, 2007
    Date of Event
    January 1, 2007
    Report Date
    January 4, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANY INFORMATION NOT INCLUDED WAS NA AT THE TIME OF THE SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    THE COMPLAINANT HAS REPORTED THAT A FEMALE PATIENT (AGE UNKNOWN) UNDERWENT A THERAPEUTIC PROCEDURE FOR URETERAL STONE RETRIEVAL IN 2007. DURING THE ATTEMPTED STONE REMOVAL, THE SHEATH (LENGTH UNKNOWN) ON THE ZERO TIP NITINOL STONE RETRIEVAL BASKET DETACHED. THE BASKET WAS REMOVED INTACT. THE CLINICIAN UTILIZED A RETRIEVAL FORCEP TO REMOVE THE DETACHED SHEATH FROM THE URETERAL ORIFICE. THE PATIENT DID NOT SUSTAIN ANY REPORTED SEQUELAE AS A RESULT OF THE DETACHED SHEATH. PATIENT CONDITION IS REPORTED AS "OK." PLEASE NOTE ASSOCIATED MEDWATCH REPORT 6000043-2007-00009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO TIP NITINOL STONE RETRIEVAL BASKET FFL FFL BOSTON SCIENTIFIC M0063901040 9154320

    Patients

    Seq Age Sex Outcome Treatment
    1 *