BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE?

    MDR report key: 3853132 · Received June 6, 2014

    Report

    Report Number
    3005099803-2014-02079
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 13, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE JAGWIRE GUIDEWIRE FOUND THAT THE PEBAX SECTION, PARTIALLY DETACHED EXPOSING THE COREWIRE TIP. THERE WAS NO EVIDENCE OF COREWIRE FRACTURE AND THE PTFE JACKET DID NOT PRESENT ANY ANOMALY. ALL THE OUTER DIAMETER MEASUREMENTS ARE WITHIN SPECIFICATIONS. THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT THAT THE DISTAL TIP DETACHED EXPOSING THE COREWIRE TIP. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILS TO INDICATE A ROOT CAUSE OR PROBABLE ROOT CAUSE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS "UNDETERMINABLE". 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.

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF GUIDEWIRE DISTAL TIP DETACHED EXPOSING THE COREWIRE TIP. 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. PATIENT IS UNDER 18 YEARS OLD.

    Description of Event or Problem · 1

    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 PHYSICIAN NOTED THAT THE DISTAL TIP OF THE JAGWIRE GUIDEWIRE WAS DETACHED INSIDE THE PATIENT EXPOSING THE COREWIRE TIP. THE DETACHED FRAGMENT WAS SUCCESSFULLY REMOVED USING A BALLOON. 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 STABLE.

    Description of Event or Problem · 1

    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 PHYSICIAN NOTED THAT THE DISTAL TIP OF THE JAGWIRE GUIDEWIRE WAS DETACHED INSIDE THE PATIENT EXPOSING THE COREWIRE TIP. THE DETACHED FRAGMENT WAS SUCCESSFULLY REMOVED USING A BALLOON. 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 STABLE.

    Description of Event or Problem · 1

    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 PHYSICIAN NOTED THAT THE DISTAL TIP OF THE JAGWIRE GUIDEWIRE WAS DETACHED INSIDE THE PATIENT EXPOSING THE COREWIRE TIP. THE DETACHED FRAGMENT WAS SUCCESSFULLY REMOVED USING A BALLOON. 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 STABLE. ADDITIONAL INFORMATION RECEIVED ON JULY 18, 2014: PROCEDURE DATE IS (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332918 JAGWIRE? STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00556581 16715322

    Patients

    Seq Age Sex Outcome Treatment
    1 Other