BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE

    MDR report key: 1981286 · Received February 8, 2011

    Report

    Report Number
    3005099803-2011-00230
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Report Date
    January 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE GUIDEWIRE FRACTURED IN TWO PARTS, NEAR FROM THE PROXIMAL END. THE ENTIRE LENGTH OF THE WIRE WAS EXAMINED (TACTILE METHOD) AND NO ANOMALIES WERE OBSERVED. THE PTFE JACKET AND POLY TIP WERE INTACT. BOTH SECTIONS WERE SENT TO THE ANALYTICAL LAB TO DETERMINE THE CAUSE OF THE FRACTURE. THE ANALYSIS REPORTED THAT "FAILURE ON BOTH SIDES PRESENT A FRACTURE OF THE HYPO TUBE, WHICH EXHIBITED EVIDENCE OF ELONGATED DIMPLE RUPTURES... NO ANOMALIES WERE FOUND. FRACTURE WAS DUE TO A BENDING OVERLOAD." OVERBENDING IS RELATED TO THE MANNER IN WHICH THE GUIDEWIRE IS HANDLED DURING THE PROCEDURE; THEREFORE, "OPERATIONAL CONTEXT" IS THE SELECTED CODE FOR THIS EVENT. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN JAGWIRE GUIDEWIRE WAS USED IN A PROCEDURE. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE PART OF THE GUIDEWIRE THAT WAS OUTSIDE OF THE DUODENOSCOPE BROKE DURING THE PROCEDURE. THE GUIDEWIRE BROKE INTO MULTIPLE PIECES, BUT NO PIECE FELL INTO THE PATIENT. IT WAS MENTIONED BY THE SITE THAT TWO COOK SPHINCTEROTOMES ALSO BROKE DURING THE PROCEDURE, AND THAT THE PROBLEM MAY HAVE BEEN DUE TO A DIFFICULT PROCEDURE OR ANATOMY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAD BEEN REPORTED AS "OK."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN JAGWIRE GUIDEWIRE WAS USED IN A PROCEDURE. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE PART OF THE GUIDEWIRE THAT WAS OUTSIDE OF THE DUODENOSCOPE BROKE DURING THE PROCEDURE. THE GUIDEWIRE BROKE INTO MULTIPLE PIECES, BUT NO PIECE FELL INTO THE PATIENT. IT WAS MENTIONED BY THE SITE THAT TWO COOK SPHINCTEROTOMES ALSO BROKE DURING THE PROCEDURE, AND THAT THE PROBLEM MAY HAVE BEEN DUE TO A DIFFICULT PROCEDURE OR ANATOMY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAD BEEN REPORTED AS "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA M00556921 13717732

    Patients

    Seq Age Sex Outcome Treatment
    1