BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE

    MDR report key: 2024061 · Received March 18, 2011

    Report

    Report Number
    3005099803-2011-00883
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 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

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE DISTAL PEBAX HAD PARTIALLY DETACHED AND THE WIRE PRESENTED TWO BENDS. NO DAMAGE WAS NOTED TO THE CORE WIRE OR THE PTFE JACKET. THE DISTAL TIP APPEARS TO HAVE BEEN IN CONTACT WITH A SHARP OR METAL OBJECT. IT IS IMPORTANT TO MENTION THAT THE EVENT HAPPENED DURING THE PROCEDURE AND THERE IS NO ALLEGED DAMAGE IN THE WIRE PRIOR TO ITS INSERTION. IT IS POSSIBLE THAT UNSTATED PROCEDURE AND POSSIBLY CLINICAL FACTORS MAY HAVE CONTRIBUTED TO THE PEBAX DETACHING FROM THE COREWIRE. ADDITIONALLY IT IS IMPORTANT TO MENTION THAT THE REMNANTS OF ADHESIVE FOUND INDICATE A PROPER ADHESION FROM THE PEBAX TO THE COREWIRE; THEREFORE, "OPERATIONAL CONTEXT" IS THE ROOT CAUSE FOR THIS INCIDENT. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2011-00882 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO JAGWIRE GUIDEWIRES WERE USED DURING A ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, THE TIPS OF BOTH GUIDEWIRES DETACHED INTO THE COMMON BILE DUCT OF THE PATIENT. IT IS UNKNOWN WHY THE TIPS DETACHED, HOWEVER THE PHYSICIAN CONSIDERED THE PIECES WOULD PASS AWAY BY THEMSELVES. THERE WERE NO PATIENT COMPLICATIONS AND THE PROCEDURE WAS COMPLETED WITH A THIRD JAGWIRE. THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS "STABLE."

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2011-00882 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO JAGWIRE GUIDEWIRES WERE USED DURING A ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, THE TIPS OF BOTH GUIDEWIRES DETACHED INTO THE COMMON BILE DUCT OF THE PATIENT. IT IS UNKNOWN WHY THE TIPS DETACHED, HOWEVER THE PHYSICIAN CONSIDERED THE PIECES WOULD PASS AWAY BY THEMSELVES. THERE WERE NO PATIENT COMPLICATIONS AND THE PROCEDURE WAS COMPLETED WITH A THIRD JAGWIRE. 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 M00556581 13612878

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR