BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE¿

    MDR report key: 2900029 · Received January 7, 2013

    Report

    Report Number
    3005099803-2012-06325
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    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 REPORTED EVENT OF TIP DETACHMENT. THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE HAVE NOT YET DETERMINED THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MANUFACTURER'S REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE TIP OF THE GUIDEWIRE HAD DETACHED, EXPOSING THE TIP OF THE METAL COREWIRE. PRESENCE OF ADHESIVE REMNANTS WAS FOUND INDICATING THAT THE PEBAX WAS PROPERLY ATTACHED TO THE CORE WIRE. NO EVIDENCE OF COREWIRE FRACTURED WAS NOTED, THE PTFE JACKET DID NOT PRESENT ANY ANOMALY, AND THE OUTER DIAMETER OF THE GUIDEWIRE WAS FOUND TO BE WITHIN SPECIFICATION. IT IS POSSIBLE THAT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED AND MAY HAVE CONTRIBUTED TO THE FAILURE; ADDITIONALLY, THE PRESENCE OF ADHESIVE WAS DETERMINED, HENCE THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND. LABELING REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO JAGWIRE GUIDEWIRES (MDR ID: 3005099803-2012-06321 AND MDR ID: 3005099803-2012-06325) WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINT, DURING UNPACKING THE FIRST JAGWIRE (B)(4) THE TIP DETACHED. A SECOND JAGWIRE (B)(4) WAS USED TO CONTINUE THE PROCEDURE. DURING THE PROCEDURE, THE TIP OF THE GUIDEWIRE DETACHED INTO THE PATIENT'S BILE DUCT. THE DETACHED FRAGMENT WAS RECOVERED WITH A BALLOON. THE PROCEDURE WAS COMPLETED WITH A THIRD 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 TWO JAGWIRE GUIDEWIRES (MDR ID: 3005099803-2012-06321 AND MDR ID: 3005099803-2012-06325) WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6), 2012. ACCORDING TO THE COMPLAINT, DURING UNPACKING THE FIRST JAGWIRE (06321) THE TIP DETACHED. A SECOND JAGWIRE (06325) WAS USED TO CONTINUE THE PROCEDURE. DURING THE PROCEDURE, THE TIP OF THE GUIDEWIRE DETACHED INTO THE PATIENT'S BILE DUCT. THE DETACHED FRAGMENT WAS RECOVERED WITH A BALLOON. THE PROCEDURE WAS COMPLETED WITH A THIRD 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
    6820 JAGWIRE¿ STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00556581 13010134

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other