BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE?

    MDR report key: 3961539 · Received July 28, 2014

    Report

    Report Number
    3005099803-2014-02517
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    May 19, 2014
    Report Date
    July 3, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF GUIDEWIRE TIP DETACHED EXPOSING THE COREWIRE TIP. A VISUAL EXAMINATION OF THE GUIDEWIRE REVEALED THAT THE DISTAL TIP WAS DAMAGED AND PARTIALLY 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. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE HYDROPHILIC TIP OF THE JAGWIRE GUIDEWIRE DETACHED OUTSIDE THE PATIENT EXPOSING THE COREWIRE TIP. THE PROCEDURE WAS COMPLETED WITH A NEW JAGWIRE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. INVESTIGATION RESULTS REVEAL ON (B)(6) 2014 THAT THE DISTAL TIP WAS PARTIALLY DETACHED EXPOSING THE COREWIRE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438091 JAGWIRE? STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00556581 0016729001

    Patients

    Seq Age Sex Outcome Treatment
    1