BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE

    MDR report key: 2123409 · Received June 14, 2011

    Report

    Report Number
    3005099803-2011-01988
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE PEBAX OF DISTAL TIP HAD PEELED AND DETACHED TO THE POINT WHERE THE TIP OF THE CORE WIRE WAS VISIBLE. THERE WAS NO FRACTURE OF THE CORE WIRE AND NO DAMAGE TO THE PTFE JACKET, HOWEVER THE GUIDEWIRE DID EXHIBIT A KINK. THE DEVICE APPEARS TO HAVE BEEN PUSHED OR PULLED AGAINST RESISTANCE. IT IS POSSIBLE THAT UNSTATED PROCEDURE AND POSSIBLY CLINICAL FACTORS MAY HAVE CONTRIBUTED TO THE GUIDEWIRE COULD NOT ADVANCED PROPERLY, CAUSING THE DAMAGE TO THE DISTAL TIP, INCLUDING BUT NOT LIMITED TO INTERACTION WITH OTHER DEVICES, HANDLING OF THE DEVICE AND CONDITION OF THE TREATED LESION. ADDITIONALLY THE REMNANTS OF ADHESIVE FOUND INDICATE THAT THE POLY TIP WAS PROPERLY ATTACHED TO THE COREWIRE. THEREFORE, "OPERATIONAL CONTEXT" IS THE MOST PROBABLE ROOT CAUSE FOR THIS INCIDENT. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING THE PLACEMENT OF A PLASTIC PROSTHESIS ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE WHILE ATTEMPTING TO ADVANCE THE GUIDEWIRE INTO THE SCOPE RESISTANCE WAS FELT AND THE GUIDEWIRE REMOVED. THE PHYSICIAN NOTED THAT THE HYDROPHILIC TIP HAD DETACHED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS "STABLE." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING THE PLACEMENT OF A PLASTIC PROSTHESIS ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE WHILE ATTEMPTING TO ADVANCE THE GUIDEWIRE INTO THE SCOPE RESISTANCE WAS FELT AND THE GUIDEWIRE REMOVED. THE PHYSICIAN NOTED THAT THE HYDROPHILIC TIP HAD DETACHED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS "STABLE." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA M0055658010 13221666

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR