BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND EX 014/205 SOFT TIP

    MDR report key: 5042563 · Received August 31, 2015

    Report

    Report Number
    3008853977-2015-00354
    Event Type
    Injury
    Date Received
    August 31, 2015
    Date of Event
    August 3, 2015
    Report Date
    August 3, 2015
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K931584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: ADDITIONAL INFORMATION WAS RECEIVED ON 08/14/2015 WHICH CHANGED THE TYPE OF REPORTABLE EVENT FROM A MALFUNCTION TO A SERIOUS INJURY AND COMPLETION OF MANUFACTURER¿S INVESTIGATION WAS ON 10/02/2015. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION AVAILABLE, THE PHYSICIAN BELIEVED THAT THE BREAK OCCURRED DUE TO OVER TORQUEING THE DEVICE. THEREFORE, A ROOT CAUSE OF HANDLING DAMAGE DURING USE HAS BEEN ASSIGNED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ANALYSIS OF THE RETURNED DEVICE FOUND IT TO BE SEPARATED AT 200.5CM FROM ITS PROXIMAL END. THE GUIDEWIRE DISTAL SEPARATED SECTION, APPROXIMATELY 4.5CM, WAS NOT RETURNED. THE GUIDEWIRE WAS SLIGHTLY BENT PROXIMAL TO THE FRACTURE SITE. MAGNIFIED EXAMINATION OF THE FRACTURE SITE SHOWED THE CORE WIRE WAS FRACTURED AND THE POLY SLEEVE WAS ALSO SEPARATED. THE GUIDEWIRE WAS BENT ON SEVERAL PLACES ALONG ITS LENGTH AND ALSO CLOSE TO THE FRACTURED SITE. FROM THE CONDITION OF THE GUIDEWIRE AT THE FRACTURE SITE, IT APPEARS THAT THE GUIDEWIRE WAS SEPARATED DUE TO EXCESSIVE MANIPULATION. IN ADDITION, THE GUIDEWIRE¿S POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS EXAMINED AND IT WAS FOUND TO BE SCRAPPED OFF AT APPROXIMATELY 42.0CM AND 68.0CM FROM ITS PROXIMAL END. FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO THE ANOMALIES FOUND ON THE PRODUCT. FROM THE CONDITION OF THE GUIDEWIRE, IT APPEARED THAT THE TORQUE DEVICE HAD BEEN DRAGGED DOWN THE GUIDEWIRE PTFE AND THE COATING APPEARED TO BE SCRAPED OFF OF THE GUIDEWIRE WITH THE TORQUE DEVICE COLLET. FROM THE SEM (SCANNING ELECTRON MICROSCOPY) IMAGES, IT APPEARS THAT THERE WAS SOME SLIGHT BOTTLENECKING AND TENSION COMPONENTS AT THE PROXIMAL FRACTURE SITE. THE GUIDEWIRE¿S HYDROPHILIC COATING WAS EXAMINED; THE COATING IS PRESENT ON THE GUIDEWIRE AND MEETS VISUAL SPECIFICATIONS. PER THE DEVICE DIRECTIONS FOR USE (DFU): "EXCESSIVE TIGHTENING OF THE TORQUE DEVICE ONTO THE WIRE MAY RESULT IN ABRASION OF THE COATING OF THE WIRE." IT IS LIKELY THAT THE PTFE SCRAPING APPEARED TO BE RELATED TO A DEVIATION FROM THE DFU. REVIEW OF THE ANALYSIS RESULTS AND THE INFORMATION AVAILABLE COULD NOT DETERMINE THE CAUSE FOR THE REPORTED GUIDEWIRE BROKEN DISTAL END AND THE UN-RETRIEVED DEVICE FRAGMENTS. THE DEVICE DIRECTIONS FOR USE (DFU) WAS REVIEWED AND THE FOLLOWING WAS FOUND: "EXERCISE CARE IN HANDLING A GUIDEWIRE DURING A PROCEDURE TO REDUCE THE POSSIBILITY OF ACCIDENTAL BREAKAGE, BENDING OR KINKING." BECAUSE THE DISTAL PORTION DETACHED/SEPARATED AND NO ACTION WAS TAKEN TO RETRIEVE THE FRAGMENT, THE UN-RETRIEVED DEVICE FRAGMENT WAS EXPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR COMMUNICATING ANEURYSM COILING PROCEDURE, THE SUBJECT GUIDEWIRE'S DISTAL END BROKE OFF WHILE IN THE BALLOON CATHETER. THE SURGERY WAS UNABLE TO BE COMPLETED AND THE PATIENT WILL UNDERGO AN ADDITIONAL SURGERY TO HAVE THE ANEURYSM CLIPPED. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR COMMUNICATING ANEURYSM COILING PROCEDURE, THE SUBJECT GUIDEWIRE'S DISTAL END BROKE OFF WHILE IN THE BALLOON CATHETER. THE SURGERY WAS UNABLE TO BE COMPLETED AND THE PATIENT WILL UNDERGO AN ADDITIONAL SURGERY TO HAVE THE ANEURYSM CLIPPED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DISTAL END OF THE GUIDEWIRE THAT BROKE OFF REMAINED IN THE PATIENT. THE PATIENT WAS REPORTED TO BE DOING FINE WITH NO PROBLEMS. INFORMATION REGARDING THE PATIENT'S ADDITIONAL SURGERY WAS NOT REPORTED. IT WAS STATED IN THE PHYSICIAN'S OPINION THE BROKEN GUIDEWIRE WAS DUE TO THE TORQUEING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR COMMUNICATING ANEURYSM COILING PROCEDURE, THE SUBJECT GUIDEWIRE'S DISTAL END BROKE OFF WHILE IN THE BALLOON CATHETER. THE SURGERY WAS UNABLE TO BE COMPLETED AND THE PATIENT WILL UNDERGO AN ADDITIONAL SURGERY TO HAVE THE ANEURYSM CLIPPED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DISTAL END OF THE GUIDEWIRE THAT BROKE OFF REMAINED IN THE PATIENT. THE PATIENT WAS REPORTED TO BE DOING FINE WITH NO PROBLEMS. INFORMATION REGARDING THE PATIENT'S ADDITIONAL SURGERY WAS NOT REPORTED. IT WAS STATED IN THE PHYSICIAN'S OPINION THE BROKEN GUIDEWIRE WAS DUE TO THE TORQUING OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575435 TRANSEND EX 014/205 SOFT TIP WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA 17712451

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other