BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE

    MDR report key: 3182500 · Received June 21, 2013

    Report

    Report Number
    3005099803-2013-05231
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. (B)(4) GUIDEWIRE DETACHED/SEPARATED. 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 REVEALED THAT THE PTFE COATING PEELED. THE COMPLAINT IS CONSISTENT WITH THE RETURN THAT THE GUIDEWIRE PTFE COATING COULD BE CONSIDERED A DEVICE'S DETACHMENT. IT IS MOST LIKELY THAT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED AND MAY HAVE CONTRIBUTED TO THE FAILURE, THEREFORE THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. BASED UPON THE INVESTIGATION RESULTS THE EVENT HAS BEEN CHANGED TO NON-REPORTABLE BASED UPON THE PTFE JACKET PEELED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING A PLACEMENT OF METAL STENT FOR PSEUDOCYST DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, POST PROCEDURE DURING A PLANNED STENT REMOVAL PROCEDURE THE PHYSICIAN NOTE THAT A PIECE OF THE JAGWIRE WAS FOUND INSIDE THE PSEUDOCYST DRAINAGE METAL STENT HOWEVER IT WAS UNABLE TO DETERMINE WHAT PART OF THE JAGWIRE IT WAS. THE FRAGMENT WAS RETRIEVED USING FORCEPS. 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 A PLACEMENT OF METAL STENT FOR PSEUDOCYST DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, POST PROCEDURE DURING A PLANNED STENT REMOVAL PROCEDURE THE PHYSICIAN NOTE THAT A PIECE OF THE JAGWIRE WAS FOUND INSIDE THE PSEUDOCYST DRAINAGE METAL STENT HOWEVER IT WAS UNABLE TO DETERMINE WHAT PART OF THE JAGWIRE IT WAS. THE FRAGMENT WAS RETRIEVED USING FORCEPS. 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
    283243 JAGWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK548

    Patients

    Seq Age Sex Outcome Treatment
    1