BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE?

    MDR report key: 4122122 · Received September 26, 2014

    Report

    Report Number
    3005099803-2014-03223
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 5, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF GUIDEWIRE DISTAL TIP DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 GUIDEWIRE REVEALED THAT THE PEBAX WAS DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. PRESENCE OF ADHESIVE REMNANTS WAS FOUND INDICATING THAT THE PEBAX WAS PROPERLY ATTACHED TO THE COREWIRE. NO EVIDENCE OF COREWIRE FRACTURED. THE PTFE JACKET DID NOT PRESENT ANY ANOMALY. 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 MOST PROBABLE ROOT CAUSE IS "HANDLING DAMAGE." SINCE THE MANUFACTURING OF THIS COMPLAINT DEVICE, A CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THIS ISSUE. 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 DURING A CHOLEDOCHOLITHIASIS TREATMENT PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE HYDROPHILIC TIP OF THE JAGWIRE GUIDEWIRE WAS DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. THE PHYSICIAN USED A BALLOON, BASKET OR FORCEPS TO RETRIEVE THE DETACHED TIP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO SERIOUS INJURIES REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING A CHOLEDOCHOLITHIASIS TREATMENT PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE HYDROPHILIC TIP OF THE JAGWIRE GUIDEWIRE WAS DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. THE PHYSICIAN USED A BALLOON, BASKET OR FORCEPS TO RETRIEVE THE DETACHED TIP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO SERIOUS INJURIES REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600317 JAGWIRE? STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0055658011 16293728

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR