BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    MDR report key: 2121094 · Received June 13, 2011

    Report

    Report Number
    3005099803-2011-01910
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Report Date
    May 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED ZERO TIP NITINOL RETRIEVAL BASKET REVEALED THE BASKET AND PULL WIRE REMAINED ATTACHED TO THE HANDLE. ALL OF THE BASKET WIRES WERE PRESENT AND ATTACHED. THE STRAIN RELIEFS (BLACK AND BLUE HEAT SHRINKS) AND OUTER SHEATH WERE DETACHED FROM THE FEMALE LUER AT THE DISTAL END OF THE HANDLE. THE FEMALE LUER COMPONENT ((B)(6)) WAS BROKEN. THE PULL WIRE WAS KINKED AT THE DISTAL END OF THE HANDLE. KINKS WERE FOUND ALONG THE OUTER SHEATH WORKING LENGTH. WITH THE LUER HELD INTO PLACE ON THE HANDLE WHILE ACTUATING, THE BASKET WOULD OPEN AND CLOSE SEVERAL TIMES WITHOUT ISSUE WHILE HELD STRAIGHT AND WHEN HELD IN A LOOP. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL/PHYSIOLOGICAL CONTEXT. IT SHOULD ALSO BE NOTED THAT THE SHEATH DETACHING FROM THE HANDLE IS NOT A MEDWATCH REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP NITINOL SONE RETRIEVAL BASKET WAS USED IN A FLEXIBLE URETEROSCOPY AND LASER LITHOTRIPSY PROCEDURE TO TREAT A PATIENT WITH RENAL STONES (PATIENT IDENTIFIER, AGE, SEX, AND WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, THE BASKET BROKE OFF RIGHT AT THE BASE OF THE HANDLE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP NITINOL SONE RETRIEVAL BASKET WAS USED IN A FLEXIBLE URETEROSCOPY AND LASER LITHOTRIPSY PROCEDURE TO TREAT A PATIENT WITH RENAL STONES (PATIENT IDENTIFIER, AGE, SEX, AND WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, THE BASKET BROKE OFF RIGHT AT THE BASE OF THE HANDLE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    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 14197765

    Patients

    Seq Age Sex Outcome Treatment
    1