BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE¿

    MDR report key: 2970387 · Received February 20, 2013

    Report

    Report Number
    3005099803-2013-00693
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE DISTAL PEBAX COATING HAD DETACHED, EXPOSING THE TIP OF THE COREWIRE. PRESENCE OF ADHESIVE REMNANTS WAS FOUND INDICATING THAT THE PEBAX WAS PROPERLY ATTACHED TO THE CORE WIRE. THE PTFE JACKET WAS FOUND PEELED, BUT THE OUTER DIAMETER OF THE GUIDEWIRE WAS FOUND TO BE WITHIN SPECIFICATIONS AND THERE WAS NO COREWIRE FRACTURE. IT IS POSSIBLE THAT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED AND MAY HAVE CONTRIBUTED TO THE FAILURE. 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. SIMILAR COMPLAINT TREND REVIEW REVEALED NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR LOT NUMBER 14470442. LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING A BILIARY LITHOTOMY ON (B)(6), 2013.ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE USING A WIRE STONE BASKET OVER THE GUIDEWIRE TO REMOVE STONES, THE TIP OF THE GUIDEWIRE DETACHED INTO THE BILE DUCT. THE DETACHED PIECE WAS SWEPT INTO THE PATIENT'S DUODENUM BY A BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH A SECOND JAGWIRE WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING A BILIARY LITHOTOMY ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE USING A WIRE STONE BASKET OVER THE GUIDEWIRE TO REMOVE STONES, THE TIP OF THE GUIDEWIRE DETACHED INTO THE BILE DUCT. THE DETACHED PIECE WAS SWEPT INTO THE PATIENT'S DUODENUM BY A BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH A SECOND JAGWIRE WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73464 JAGWIRE¿ STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0055658011 14470442

    Patients

    Seq Age Sex Outcome Treatment
    1 Other