BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE?

    MDR report key: 3232638 · Received July 18, 2013

    Report

    Report Number
    3005099803-2013-07041
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. (B)(4) FOR THE REPORTED EVENT OF GUIDEWIRE DISTAL HYDROPHILIC TIP DETACHED THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE PEBAX SECTION WAS DAMAGED. THE PEBAX PRESENTS A PEELED SECTION AND THE DISTAL TIP DETACHED EXPOSING THE COREWIRE TIP, APPROXIMATELY 1.5CM. THE DEVICE ANALYSIS ALSO FOUND A KINK APPROXIMATELY 5.5CM FROM DISTAL END. PRESENCE OF ADHESIVE REMNANTS WAS FOUND INDICATING THAT THE PEBAX WAS PROPERLY ATTACHED TO THE COREWIRE. NO EVIDENCE OF COREWIRE FRACTURED. THE PTFE JACKET DID NOT PRESENT ANY ANOMALY. ALL OUTER DIAMETER MEASUREMENTS ARE WITHIN THE SPECIFICATIONS. THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DISTAL TIP DETACHED EXPOSING THE CORE WIRE TIP. IT IS POSSIBLE THAT UNSTATED PROCEDURE AND POSSIBLY CLINICAL FACTORS MAY HAVE CONTRIBUTED TO THE DEVICE DAMAGE, INCLUDING BUT NOT LIMITED TO INTERACTION WITH OTHER DEVICES, HANDLING OF THE DEVICE AND CONDITION OF THE TREATED LESION. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPRATIONAL CONTEXT. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND. THERE HAVE BEEN NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR LOT NUMBER 14316594.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE HYDROPHILIC TIP OF THE GUIDEWIRE DETACHED OUTSIDE THE PATIENT, EXPOSING THE TIP OF THE METAL COREWIRE. THE PROCEDURE WAS COMPLETED WITH A NEW JAGWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE HYDROPHILIC TIP OF THE GUIDEWIRE DETACHED OUTSIDE THE PATIENT, EXPOSING THE TIP OF THE METAL COREWIRE. THE PROCEDURE WAS COMPLETED WITH A NEW JAGWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333925 JAGWIRE? STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00556581 14316594

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR