BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE?

    MDR report key: 3252253 · Received July 29, 2013

    Report

    Report Number
    3005099803-2013-08188
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 EXAMINATION REVEALED THAT THE PEBAX SECTION DETACHED, EXPOSING APPROXIMATELY 1.7 CM OF THE TIP OF THE METAL CORE WIRE. THE DISTAL TIP PRESENTS THE PEBAX PEELED. THE PEBAX SECTION HAD PRESENCE OF ADHESIVE REMNANTS INDICATING THAT THE PEBAX WAS PROPERLY ATTACHED TO THE CORE WIRE. NO EVIDENCE OF CORE WIRE FRACTURE NOTED AND THE PTFE JACKET DID NOT PRESENT ANY ANOMALY. THE OUTER DIAMETER OF THE GUIDEWIRE WAS MEASURED AND FOUND TO BE WITH SPECIFICATION. THE COMPLAINT IS CONSISTENT WITH THE RETURN THE PEBAX SECTION DETACHED EXPOSING THE TIP OF THE CORE WIRE AND THE DISTAL TIP SECTION PEELED. IT IS MOST LIKELY 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 OPERATIONAL CONTEXT. 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 A BILIARY STENTING PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE USING AN ULTRATOME AND JAGWIRE CBD WAS CANNULATED WHEN SPHINCTEROTOMY WAS DONE THE GUIDEWIRE WAS EXCHANGED. A BILIARY DILATION BALLOON WAS PLACED INSIDE THE CBD TO DILATE THE DUCT. WHEN THE BALLOON WAS TAKEN OUT THE PLASTIC STENT WAS BACKLOADED IN THE GUIDEWIRE AND STENTING WAS PERFORMED. THE PHYSICIAN NOTICED THAT THE DISTAL TIP OF THE GUIDEWIRE BROKE WHEN HE TOOK IT OUT THE DEVICE. THE FRAGMENT WAS NOT FOUND UNDER FLUOROSCOPY. THE PROCEDURE WAS COMPLETED WITH A NEW JAGWIRE GUIDEWIRE. NO PATIENT SERIOUS INJURY WAS 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 GUIDEWIRE WAS USED DURING A BILIARY STENTING PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE USING AN ULTRATOME AND JAGWIRE CBD WAS CANNULATED WHEN SPHINCTEROTOMY WAS DONE, THE GUIDEWIRE WAS EXCHANGED. A BILIARY DILATION BALLOON WAS PLACED INSIDE THE CBD TO DILATE THE DUCT. WHEN THE BALLOON WAS TAKEN OUT, THE PLASTIC STENT WAS BACKLOADED IN THE GUIDEWIRE AND STENTING WAS PERFORMED. THE PHYSICIAN NOTICED THAT THE DISTAL TIP OF THE GUIDEWIRE BROKE WHEN HE TOOK IT OUT THE DEVICE. THE FRAGMENT WAS NOT FOUND UNDER FLUOROSCOPY. THE PROCEDURE WAS COMPLETED WITH A NEW JAGWIRE GUIDEWIRE. NO PATIENT SERIOUS INJURY WAS 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
    352230 JAGWIRE? STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0055658011 15330930

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR