BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    MDR report key: 2143147 · Received June 28, 2011

    Report

    Report Number
    3005099803-2011-02109
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED ZERO TIP NITINOL RETRIEVAL BASKET REVEALED THAT THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE DEVICE BASKET WIRE WAS BROKEN. ALL OF THE BASKET WIRES WERE PRESENT AND ATTACHED; HOWEVER, ONE (1) OF THE BASKET WIRES WAS BROKEN AT THE DISTAL KNOT. THE ENTIRE BROKEN WIRE WAS PRESENT. THE HANDLE WAS ACTUATED; THE BASKET WOULD CLOSE AND OPEN WITHOUT ISSUE. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE. IT SHOULD ALSO BE NOTED THAT A WIRE BREAKING BUT NOT FULLY DETACHING FROM THE BASKET IS NOT A MEDWATCH REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP NITINOL RETRIEVAL BASKET WAS USED IN A URETEROSCOPY PROCEDURE. THE PATIENT WAS REPORTED TO BE OVER 18 YEARS. (PATIENT IDENTIFIER, AGE, WEIGHT, AND SEX UNKNOWN). ACCORDING TO THE COMPLAINANT, THE BASKET AND NOTICED TO BE BROKEN WHEN THEY OPENED THE PACKAGE. ONE OF THE BASKET "ARMS" WAS NOT ATTACHED. INSTEAD OF A 4 ARM BASKET, ONLY 3 ARMS WERE ATTACHED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND ZERO TIP NITINOL RETRIEVAL BASKET. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THERE WERE NO ISSUES REPORTED TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP NITINOL RETRIEVAL BASKET WAS USED IN A URETEROSCOPY PROCEDURE. THE PATIENT WAS REPORTED TO BE OVER 18 YEARS. (PATIENT IDENTIFIER, AGE, WEIGHT, AND SEX UNKNOWN) ACCORDING TO THE COMPLAINANT, THE BASKET AND NOTICED TO BE BROKEN WHEN THEY OPENED THE PACKAGE. ONE OF THE BASKET "ARMS" WAS NOT ATTACHED. INSTEAD OF A 4 ARM BASKET, ONLY 3 ARMS WERE ATTACHED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND ZERO TIP NITINOL RETRIEVAL BASKET. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THERE WERE NO ISSUES REPORTED TO THE PATIENT.

    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 14319854

    Patients

    Seq Age Sex Outcome Treatment
    1