BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE¿

    MDR report key: 2882623 · Received December 20, 2012

    Report

    Report Number
    3005099803-2012-05877
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF TIP DETACHED. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. IF THE DEVICE IS RETURNED UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED GUIDEWIRE REVEALED THAT THE PEBAX TIP HAD DETACHED, EXPOSING THE TIP OF THE METAL COREWIRE. PRESENCE OF ADHESIVE REMNANTS WERE FOUND ON THE COREWIRE, INDICATING THAT THE PEBAX HAD BEEN PROPERLY ATTACHED TO THE CORE WIRE. THE PTFE JACKET AND COREWIRE DID NOT REVEAL ANY DAMAGE AND THE OUTER DIAMETER OF THE GUIDEWIRE WAS FOUND TO BE WITHIN SPECIFICATION. IT IS POSSIBLE THAT DURING THE CLINICAL ATTEMPT (UNPACKING/PREPARATION) THE DEVICE COULD BE HANDLED IMPROPERLY, THEREBY, CAUSING THE DAMAGE FOUND. THEREFORE, "HANDLING DAMAGE" IS THE MOST PROBABLE ROOT CAUSE FOR THIS INCIDENT. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2012-05876 AND 3005099803-2012-05877 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO JAGWIRE GUIDEWIRES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT WHEN THE FIRST JAGWIRE WAS INSERTED INTO A TOME THE TIP DETACHED, EXPOSING THE TIP OF THE COREWIRE. A SECOND JAGWIRE WAS OPENED, HOWEVER THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS STABLE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2012-05876 AND 3005099803-2012-05877 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO JAGWIRE GUIDEWIRES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT WHEN THE FIRST JAGWIRE WAS INSERTED INTO A TOME THE TIP DETACHED, EXPOSING THE TIP OF THE COREWIRE. A SECOND JAGWIRE WAS OPENED, HOWEVER THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED 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 (COYOL) M0055658011 14102168

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR