BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE?

    MDR report key: 4221184 · Received November 3, 2014

    Report

    Report Number
    3005099803-2014-03441
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    September 28, 2014
    Report Date
    October 9, 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

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE GUIDEWIRE REVEALED THAT THE DISTAL TIP WAS PEELED AND BENT, APPROXIMATELY 2.3 CM FROM DISTAL END WITH A LENGTH OF 0.3CM. PRESENCE OF ADHESIVE REMNANTS WERE 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 NOT 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2014-03440 AND 3005099803-2014-03441 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. 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, WHILE THE PHYSICIAN WAS ADVANCING THE JAGWIRE GUIDEWIRE INTO THE PATIENT, THE HYDROPHILIC TIP DETACHED INSIDE THE PATIENT EXPOSING THE TIP OF THE METAL COREWIRE. THE PHYSICIAN SPENT NEARLY AN HOUR TO SUCCESSFULLY RETRIEVE THE DETACHED TIP. THE PHYSICIAN USED A SECOND JAGWIRE GUIDEWIRE, HOWEVER, DURING PREPARATION, THE HYDROPHILIC TIP ALSO DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2014-03440 AND 3005099803-2014-03441 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. 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, WHILE THE PHYSICIAN WAS ADVANCING THE JAGWIRE GUIDEWIRE INTO THE PATIENT, THE HYDROPHILIC TIP DETACHED INSIDE THE PATIENT EXPOSING THE TIP OF THE METAL COREWIRE. THE PHYSICIAN SPENT NEARLY AN HOUR TO SUCCESSFULLY RETRIEVE THE DETACHED TIP. THE PHYSICIAN USED A SECOND JAGWIRE GUIDEWIRE, HOWEVER, DURING PREPARATION, THE HYDROPHILIC TIP ALSO DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703352 JAGWIRE? STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00556581 16293730

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR