BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE¿

    MDR report key: 2162408 · Received July 14, 2011

    Report

    Report Number
    3005099803-2011-02403
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF TIP DETACHMENT. 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 THAT THE TIP OF THE PEBAX HAD DETACHED, EXPOSING THE COREWIRE, NO OTHER DAMAGE WAS NOTED. AS THE DEVICE PRESENTS EVIDENCE OF THE GLUE USED TO ATTACHED THE PEBAX TO THE CORE WIRE, THE ROOT CAUSE IS CONSIDERED OPERATIONAL CONTEXT SINCE DUE TO AN ANATOMICAL OR PROCEDURAL FACTORS FOUND DURING THE PROCEDURE AN EXCESSIVE FORCE SEEMS TO BE APPLIED LIMITING THE PERFORMANCE OF THE UNIT. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND. LABELING REVIEW PERFORMED AND NO ANOMALY WAS FOUND.

    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 # 3005099803-2011-02404 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO JAGWIRE GUIDEWIRES WERE USED IN AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) ON (B)(6) 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, WHILE INSERTING THE FIRST JAGWIRE THE TIP DETACHED OFF INSIDE OF THE PATIENT. TH PHYSICIAN RETRIEVED THE DETACHED PIECE AND THE WIRE AND A SECOND JAGWIRE WAS USED. THE TIP OF THIS GUIDEWIRE ALSO DETACHED AND WAS RETRIEVED. A THIRD JAGWIRE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS. 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 # 3005099803-2011-02404 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO JAGWIRE GUIDEWIRES WERE USED IN AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, WHILE INSERTING THE FIRST JAGWIRE THE TIP DETACHED OFF INSIDE OF THE PATIENT. TH PHYSICIAN RETRIEVED THE DETACHED PIECE AND THE WIRE AND A SECOND JAGWIRE WAS USED. THE TIP OF THIS GUIDEWIRE ALSO DETACHED AND WAS RETRIEVED. A THIRD JAGWIRE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS. 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 12553970

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention