BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZ SUPERSTIFF GUIDEWIRE

    MDR report key: 1981865 · Received February 8, 2011

    Report

    Report Number
    3005099803-2011-00369
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    November 18, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - GUIDEWIRE AND (B)(4) - TIP RELATES TO (B)(4) AND (B)(4) FOR THE REPORTED EVENT OF GUIDEWIRE TIP FRAYED AND DETACHED. SCANNING ELECTRON MICROSCOPY (SEM) FOR FRACTURE ANALYSIS WAS PERFORMED. THE SUSPECT DEVICE, AN AMPLATZ POLYTETRAFLUOROETHYLENE (PTFE) .035 SUPERSTIFF GUIDEWIRE WAS RETURNED AND VISUALLY INSPECTED. IT WAS OBSERVED THAT THE GUIDEWIRE WAS SEVERELY ELONGATED AND UNRAVELED AND THE DISTAL TIP SECTION SEPARATED/DETACHED APPROXIMATELY 3CM WITH THE CORE WIRE INTACT BUT SEPARATED FROM THE BALLWELD. THE ENTIRE LENGTH OF THE WIRE WAS EXAMINED AND THE CORE WIRE WAS OBSERVED AS KINKED AT 2 CM, 7CM AND 9 CM FROM THE DISTAL END. THE DEVICE APPEARS SEVERELY DAMAGED AND THERE IS EVIDENCE OF CORE WIRE FRACTURE. THE FRACTURED SECTIONS WERE SENT TO SEM (SCANNING ELECTRON MICROSCOPY) FOR FRACTURE ANALYSIS. THE SEM RESULTS REVEALED THAT WITHIN THE PRIMARY AND SECONDARY DISTAL AND PROXIMAL FRACTURE SITES AND SURFACE OF THE FLAT RIBBON COIL, EVIDENCE OF COMPRESSION AND TENSION INDICATIVE OF A BENDING OVERLOAD MOTION. THE FLAT RIBBON SPLIT OPEN ALONG THE LONGITUDINAL GRAIN BOUNDARIES THAT APPEAR AS A FIBROUS MATERIAL. THE FRACTURE SURFACE EXHIBITED FATIGUE STRIATIONS, MICROCRACKS AND DIMPLED RUPTURES IN THE TEAR. THE CORE WIRE FRACTURE SITE AND SURFACE EXHIBITED ELONGATED DIMPLE RUPTURES IN A TORSIONAL DIRECTION. NO MATERIAL ANOMALIES WERE NOTED ON THE FRACTURES. BASED ON THE ANALYSES PERFORMED, IT WAS CONCLUDED THAT THE CORE WIRE FRACTURED DUE TO A TORSIONAL OVERLOAD. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED WHICH CONTAINS THE PRODUCTION HISTORY OF A FINISHED DEVICE AND FOUND NO ANOMALIES THAT ARE RELATED TO THE FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPERSTIFF UROLOGICAL GUIDEWIRE WAS USED IN AN UNKNOWN PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AN AMPLATZ SUPERSTIFF GUIDEWIRE FRAYED AT THE TIP WHEN INSERTED INTO THE DUAL LUMEN CATHETER. THE TIP OF THE DEVICE DETACHED WITHIN THE PATIENT AND WAS RETRIEVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECOND AMPLATZ SUPERSTIFF GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED. NOTE: THE EVENT, AS REPORTED, DID NOT REFLECT AN MDR-REPORTABLE SCENARIO. HOWEVER, EVALUATION OF THE RETURNED AMPLATZ SUPERSTIFF GUIDEWIRE REVEALED AN MDR-REPORTABLE MALFUNCTION OF THE COREWIRE BEING FRACTURED. THE MDR IS BASED UPON THE EVALUATION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZ SUPERSTIFF GUIDEWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA M0066401041 13653250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention