BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE

    MDR report key: 1911806 · Received December 1, 2010

    Report

    Report Number
    3005099803-2010-04977
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    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

    VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED APPROXIMATELY 4.5CM OF THE DISTAL TIP PEBAX COATING HAD DETACHED, EXPOSING THE COREWIRE OF THE DEVICE. THE EXPOSED CORE WIRE WAS NOTED TO BE SLIGHTLY SCRAPED; NO FRACTURE OF THE CORE WIRE WAS OBSERVED. THE DEVICE APPEARS TO HAVE BEEN IN CONTACT WITH A SHARP OR METAL OBJECT. EVIDENCE OF ADHESIVE WAS FOUND ON THE CORE WIRE, INDICATING THE PEBAX COATING HAD BEEN PROPERLY ATTACHED. NO DAMAGE WAS NOTED TO THE PTFE JACKET OF THE GUIDEWIRE. THE OUTER DIAMETER OF THE DEVICE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. BASED ON THE CONDITION OF THE RETURNED DEVICE AND AS THE REPORTED EVENT OCCURRED DURING THE PROCEDURE, THE MOST PROBABLE ROOT CAUSE IS "CAUSED BY OTHER DEVICE."

    Additional Manufacturer Narrative · 1

    (B)(4) THE REPORTED EVENT OF GUIDEWIRE TIP DETACHMENT. 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 MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED DURING A STONE EXTRACTION PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A PLASTIC BILIARY STENT WAS DEPLOYED AND THE DISTAL TIP OF THE GUIDEWIRE DETACHED IN THE COMMON BILE DUCT OF THE PATIENT. THE PHYSICIAN COULD NOT DO ANYTHING TO RETRIEVE THE FRAGMENT AND BELIEVED IT WOULD PASS NATURALLY. THE PROCEDURE HAD BEEN COMPLETED WITH THIS DEVICE. 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 A STONE EXTRACTION PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A PLASTIC BILIARY STENT WAS DEPLOYED AND THE DISTAL TIP OF THE GUIDEWIRE DETACHED IN THE COMMON BILE DUCT OF THE PATIENT. THE PHYSICIAN COULD NOT DO ANYTHING TO RETRIEVE THE FRAGMENT AND BELIEVED IT WOULD PASS NATURALLY. THE PROCEDURE HAD BEEN COMPLETED WITH THIS DEVICE. 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
    1 JAGWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA M0055660011 13218432

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR PLASTIC BILIARY STENT (UNKNOWN BRAND/MODEL)