BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE?

    MDR report key: 3894724 · Received June 25, 2014

    Report

    Report Number
    3005099803-2014-02341
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE GUIDEWIRE REVEALED THAT THE DISTAL TIP WAS DETACHED EXPOSING THE TIP OF THE METAL COREWIRE THE PEBAX SECTION WAS NOT RETURNED AND PRESENCE OF ADHESIVE REMNANTS WERE NOT FOUND. THE COMPLAINT IS CONSISTENT WITH THE RETURN THAT THE DISTAL TIP WAS DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. BASED ON ALL GATHERED INFORMATION THE INVESTIGATION FAILS TO DETERMINE A DEFINITE ROOT CAUSE. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. 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. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2014-02341 AND 3005099803-2014-02340 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6), 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DISTAL TIP OF THE JAGWIRE GUIDEWIRE DETACHED INSIDE THE PATIENT EXPOSING THE METAL COREWIRE TIP. A SECOND JAGWIRE GUIDEWIRE WAS USED HOWEVER, THE DISTAL TIP WAS ALSO DETACHED INSIDE THE PATIENT EXPOSING THE METAL COREWIRE TIP. THE DETACHED TIP REMAINED IN THE PANCREATIC DUCT. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT HAD A PROLONGED HOSPITAL STAY AS A RESULT OF THIS EVENT. THE PATIENT¿S CURRENT CONDITION WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2014-02341 AND 3005099803-2014-02340 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DISTAL TIP OF THE JAGWIRE GUIDEWIRE DETACHED INSIDE THE PATIENT EXPOSING THE METAL COREWIRE TIP. A SECOND JAGWIRE GUIDEWIRE WAS USED HOWEVER, THE DISTAL TIP WAS ALSO DETACHED INSIDE THE PATIENT EXPOSING THE METAL COREWIRE TIP. THE DETACHED TIP REMAINED IN THE PANCREATIC DUCT. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT HAD A PROLONGED HOSPITAL STAY AS A RESULT OF THIS EVENT. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371854 JAGWIRE? STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00556581 16830958

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization