BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE

    MDR report key: 2162382 · Received July 14, 2011

    Report

    Report Number
    3005099803-2011-02402
    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
    SE
    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 THAT THE PEBAX TIP HAD DETACHED, REVEALING THE COREWIRE. NO OTHER ANOMALIES WERE NOTED. 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. LABELING REVIEW PERFORMED AND NO ANOMALY WAS FOUND. SIMILAR COMPLAINT TREND REVIEW REVEALED NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THE LOT NUMBER 14224268. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE TO PLACE A STENT FOR BILIARY DRAINAGE ON (B)(6), 2011, ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, WHEN THE JAGWIRE WAS ATTEMPTED TO BE ADVANCED, THE TIP OF THE JAGWIRE DETACHED INSIDE OF THE PATIENT. ATTEMPTS WERE MADE TO RECOVER THE DETACHED PIECE, BUT WERE UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGWIRE WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS "STABLE" IN ADDITION, THE PATIENT HAS AN MALIGNANCY (CURABLE) IN PANCREAS AND WILL THEREFORE BE OPERATED AND THE SITE HOPES TO REMOVE THE DETACHED PIECE DURING THAT OPERATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE TO PLACE A STENT FOR BILIARY DRAINAGE ON (B)(6), 2011, ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, WHEN THE JAGWIRE WAS ATTEMPTED TO BE ADVANCED, THE TIP OF THE JAGWIRE DETACHED INSIDE OF THE PATIENT. ATTEMPTS WERE MADE TO RECOVER THE DETACHED PIECE, BUT WERE UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGWIRE WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS "STABLE" IN ADDITION, THE PATIENT HAS AN MALIGNANCY (CURABLE) IN PANCREAS AND WILL THEREFORE BE OPERATED AND THE SITE HOPES TO REMOVE THE DETACHED PIECE DURING THAT OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA M00557640 14224268

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention