BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    MDR report key: 1915130 · Received December 6, 2010

    Report

    Report Number
    3005099803-2010-05071
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    October 30, 2010
    Report Date
    November 11, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED ZERO-TIP NITINOL RETRIEVAL BASKET THE BASKET WAS OPEN. ALL OF THE BASKET WIRES WERE PRESENT; HOWEVER, ONE (1) OF THE BASKET WIRES WAS BROKEN. THE BROKEN WIRE WAS ATTACHED. SEVERAL KINKS WERE IDENTIFIED ON THE OUTER SHEATH. A FUNCTIONAL EVALUATION REVEALED THE DEVICE WOULD OPEN AND CLOSE WHEN THE HANDLE WAS ACTUATED; THE DISTAL END OF THE BROKEN WIRE WOULD NOT CLOSE INTO THE OUTER SHEATH. THE KINKS AND BREAK WERE MOST LIKELY DUE TO SOME ASPECT OF THE PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS DETERMINED TO BE OPERATIONAL/PHYSIOLOGICAL CONTEXT. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE ACCEPTED DEVICES MET ALL MANUFACTURING SPECIFICATIONS. IT IS ALSO NOTED THAT AFTER A THOROUGH INVESTIGATION, THE EVENTS OF KINKING AND BASKET WIRE SEPARATING FROM THE KNOT AND REMAINING ATTACHED TO THE DEVICE ARE NOT MEDWATCH REPORTABLE CONDITIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP NITINOL RETRIEVAL BASKET WAS BEING USED IN AN UNSPECIFIED PROCEDURE. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS DEFECTIVE. THE EXACT DEFECT IS UNKNOWN. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. THE COMPLAINANT WAS UNABLE TO PROVIDE PATIENT DETAILS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP NITINOL RETRIEVAL BASKET WAS BEING USED IN AN UNSPECIFIED PROCEDURE. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS DEFECTIVE. THE EXACT DEFECT IS UNKNOWN. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. THE COMPLAINANT WAS UNABLE TO PROVIDE PATIENT DETAILS.

    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 M0063901050 13784522

    Patients

    Seq Age Sex Outcome Treatment
    1