BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE?

    MDR report key: 4123438 · Received September 26, 2014

    Report

    Report Number
    3005099803-2014-03228
    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
    OTHER

    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. 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.

    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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF SIX DEVICES THAT WERE INSPECTED. REFER TO MANUFACTURER REPORT #3005099803-2014-03227, 3005099803-2014-03228, 3005099803-2014-03229, 3005099803-2014-03230, 3005099803-2014-03231 AND 3005099803-2014-03232 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS INSPECTED. ACCORDING TO THE COMPLAINANT, SINCE THE EVENT, HYDROPHILIC TIP DETACHED, OCCURRED SEVERAL TIMES, THE USER UNPACKED THE JAGWIRE GUIDEWIRE AND FOUND THAT THE HYDROPHILIC TIP WAS DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. FIVE MORE JAGWIRE GUIDEWIRES WERE OPENED AND THE HYDROPHILIC TIP ALSO DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF SIX DEVICES THAT WERE INSPECTED. REFER TO MANUFACTURER REPORT #3005099803-2014-03227, 3005099803-2014-03228, 3005099803-2014-03229, 3005099803-2014-03230, 3005099803-2014-03231 AND 3005099803-2014-03232 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS INSPECTED. ACCORDING TO THE COMPLAINANT, SINCE THE EVENT, HYDROPHILIC TIP DETACHED, OCCURRED SEVERAL TIMES, THE USER UNPACKED THE JAGWIRE GUIDEWIRE AND FOUND THAT THE HYDROPHILIC TIP WAS DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. FIVE MORE JAGWIRE GUIDEWIRES WERE OPENED AND THE HYDROPHILIC TIP ALSO DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602339 JAGWIRE? STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0055658011 16293728

    Patients

    Seq Age Sex Outcome Treatment
    1