BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    MDR report key: 1914171 · Received December 3, 2010

    Report

    Report Number
    3005099803-2010-04927
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED ZERO TIP NITINOL RETRIEVAL BASKET REVEALED THE BASKET WIRE WAS BROKEN; HOWEVER, THE BASKET WOULD OPEN AND CLOSE WITHOUT ISSUE. BASED ON THE ANALYSIS, IT HAS BEEN DETERMINED THAT ONE (1) OF THE BASKET WIRES WAS BROKEN; THE BROKEN WIRE REMAINED ATTACHED TO THE WIRE SUB-ASSEMBLY. THE BROKEN BASKET WIRE DID NOT IMPACT BASKET¿S ABILITY TO OPEN AND CLOSE. THE BROKEN BASKET WIRE IS CONSISTENT WITH THOSE THAT ARE CAUSED WHEN THE WIRE IS PUT UNDER STRESS DURING A PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS DETERMINED TO BE OPERATIONAL/PHYSIOLOGICAL CONTEXT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP NITINOL RETRIEVAL BASKET WAS USED DURING A URETEROSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, ONE OF THE WIRES SEPARATED FROM THE KNOT AFTER IT WAS PLACED IN THE URETER AND THE STONE BECAME ENTRAPPED IN THE BASKET. NO PART OF THE BASKET DETACHED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER ZERO TIP NITINOL RETRIEVAL BASKET. THE PATIENT WAS REPORTED TO BE "FINE" 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 USED DURING A URETEROSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, ONE OF THE WIRES SEPARATED FROM THE KNOT AFTER IT WAS PLACED IN THE URETER AND THE STONE BECAME ENTRAPPED IN THE BASKET. NO PART OF THE BASKET DETACHED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER ZERO TIP NITINOL RETRIEVAL BASKET. THE PATIENT WAS REPORTED TO BE "FINE" 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 M0063901050 13722334

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR