BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE

    MDR report key: 2022887 · Received March 18, 2011

    Report

    Report Number
    3005099803-2011-00828
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    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

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT YET BEEN COMPLETED. UPON 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 OF THE RETURNED DEVICE REVEALED NO ANOMALIES. THE DISTAL TIP DID NOT HAVE ANY SECTION MISSING AND THE PTFE JACKET SHOWED NO EVIDENCE OF BEING DAMAGED. THE COMPLAINT WAS NOT CONFIRMED. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND. THE SITE WAS CONTACTED AND WERE UNABLE TO CONFIRM THAT THE CORRECT DEVICE WAS RETURNED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE AFTER THE PHYSICIAN USED THE JAGWIRE GUIDEWIRE TO COMPLETE THE OPERATION, HE NOTICED THE PORTION OF THE TIP OF GUIDEWIRE HAD DETACHED. NO ATTEMPT WAS MADE TO RETRIEVE THE TIP AS THE PHYSICIAN BELIEVED THE TIP WILL "DISCHARGE AUTOMATICALLY". THERE WERE NO PATIENT COMPLICATIONS AND 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 AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE AFTER THE PHYSICIAN USED THE JAGWIRE GUIDEWIRE TO COMPLETE THE OPERATION, HE NOTICED THE PORTION OF THE TIP OF GUIDEWIRE HAD DETACHED. NO ATTEMPT WAS MADE TO RETRIEVE THE TIP AS THE PHYSICIAN BELIEVED THE TIP WILL "DISCHARGE AUTOMATICALLY". THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA M0055658010 13701864

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR