BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE GUIDWIRE

    MDR report key: 10269758 · Received July 14, 2020

    Report

    Report Number
    9681834-2020-00140
    Event Type
    Injury
    Date Received
    July 14, 2020
    Date of Event
    June 26, 2020
    Report Date
    July 14, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    OCY
    PMA / PMN Number
    K091417
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. ON (B)(6) 2020, IT WAS CONFIRMED THAT THE ACTUAL SAMPLE WAS NOT INFECTIOUS. VISUAL INSPECTION REVEALED THAT THE DISTAL END HAD BEEN FRACTURED. THE FRACTURED FRAGMENT WAS NOT RETURNED FOR EVALUATION. THE ACTUAL SAMPLE WAS COMPARED WITH A RETENTION SAMPLE OF THE INVOLVED PRODUCT CODE. IT WAS CONFIRMED THAT 0-120 MM FROM THE DISTAL END WAS MISSING. MAGNIFYING INSPECTION REVEALED THAT THE PTFE COATING HAD BEEN EXFOLIATED ON THE AREA 0-30 MM FROM THE FRACTURE END, A KINK HAD BEEN GENERATED AT APPROXIMATELY 5 MM FROM THE FRACTURE END, THE FRACTURE END HAD NOT BEEN CURVED OR TAPERED, AND THE CORE WIRE NEAR THE FRACTURE END HAD BEEN DISCOLORED. THE FRACTURE END WAS INSPECTED WITH SEM. RADIAL PATTERN WAS OBSERVED ON THE FRACTURE CROSS SECTION. FROM THIS, IT WAS LIKELY THAT TORQUE FORCE WAS APPLIED TO THE ACTUAL SAMPLE. IN ADDITION, A PART OF THE FRACTURE CROSS SECTION HAD BEEN STEPPED. THIS STEP-LIKE FRACTURE SURFACE WAS FOUND AT THE SAME POSITION AS THE DISCOLORED PART OF THE CORE WIRE WAS OBSERVED. MAGNIFYING INSPECTION OF THE KINKED AREA FOUND THAT PTFE COATING HAD BEEN EXFOLIATED. FROM THIS, IT WAS LIKELY THAT THE ACTUAL SAMPLE WAS SUBJECTED TO ABRADING FORCE, WHICH CAUSED THE EXFOLIATION OF PTFE COATING, AND SUBSEQUENTLY, WAS SUBJECTED TO BENDING FORCE WITH RESULTANT GENERATION OF THE KINK. MAGNIFYING INSPECTION OF THE EXFOLIATION OF PTFE COATING FOUND THAT THE EXFOLIATION OCCURRED FROM PROXIMAL TO DISTAL DIRECTION. FROM THIS, IT WAS LIKELY THAT THE EXFOLIATION OF PTFE OCCURRED WHEN THE ACTUAL SAMPLE WAS PULLED IN THE WITHDRAWAL DIRECTION. THE INTACT SECTION OF THE ACTUAL SAMPLE WAS SPLIT TO CONFIRM THE STATE OF ADHESION OF PTFE COATING TO THE CORE WIRE. IT WAS CONFIRMED TO BE COMPARABLE TO THAT OF THE RETENTION SAMPLE, AND NO GAP OR NO OTHER ANOMALY WAS OBSERVED. THE OUTER DIAMETER OF THE SHAFT ON THE UNDAMAGED WAS MEASURED AND CONFIRMED TO MEET THE MANUFACTURER SPECIFICATION. THE OUTER DIAMETER OF THE CORE WIRE WAS MEASURED NEAR THE FRACTURE AND CONFIRMED TO BE COMPARABLE TO THAT OF THE RETENTION SAMPLE (AT APPROXIMATELY 120 MM FROM ITS DISTAL END). PTFE COATING SECTION (DISTAL SIDE): 0.570 MM, PTFE COATING SECTION (PROXIMAL SIDE): 0.569 MM, CORE WIRE NEAR THE FRACTURE: 0.439 MM; CORE WIRE OF THE RETENTION SAMPLE (AT APPROXIMATELY 120 MM FROM THE DISTAL END): 0.439 MM. BENDING STRENGTH OF THE SHAFT WAS MEASURED AND CONFIRMED TO MEET THE FACTORY'S CONTROL CRITERIA. NO ANOMALY WAS NOTED. REPRODUCTIVE TESTING WAS PERFORMED: FRACTURE OF THE GUIDE WIRE; A GUIDEWIRE SAMPLE IN A CURVED STATE WAS SUBJECTED TO REPETITIVE ONE-WAY TORQUE FORCE UNTIL IT BECAME FRACTURED. AS A RESULT, RADIAL PATTERN WAS OBSERVED ON THE FRACTURE SURFACE OF THE CORE WIRE. EXFOLIATION OF PTFE COATING- 1: A GUIDEWIRE SAMPLE WAS WITHDRAWN PROXIMALLY WHILE A METAL PLATE WAS PUT ON THE PTFE COATING. AS A RESULT, PTFE COATING WAS SHEARED OFF IN THE DISTAL DIRECTION. WHEN THE GUIDE WIRE WAS PUSHED FORWARD, THE PTFE COATING WAS SHEARED OFF IN THE PROXIMAL DIRECTION. EXFOLIATION OF PTFE COATING- 2: A GUIDEWIRE SAMPLE WAS INSERTED IN AN ENDOSCOPE AND THE ENDOSCOPE'S FORCEPS ELEVATOR WAS RAISED. SUBSEQUENTLY, THE GUIDE WIRE IN THAT STATE WAS MANIPULATED FORWARD AND BACKWARD. AS A RESULT, THE GUIDEWIRE WAS ABRADED EXCESSIVELY BY THE FORCEPS ELEVATOR, WHICH RESULTED IN THE EXFOLIATION OF PTFE COATING. IFU STATES: IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GUIDE WIRE AND/OR ENDOTHERAPY ACCESSORY AND DETERMINE THE CAUSE BY FLUOROSCOPY OR ENDOSCOPE. CONTINUING TO MANIPULATE THE GUIDEWIRE COULD CAUSE PATIENT INJURY, SUCH AS PUNCTURES, HEMORRHAGES OR MUCOUS MEMBRANE DAMAGE. IT MAY ALSO DAMAGE THE ENDOSCOPE, INSTRUMENT AND/OR ENDOTHERAPY ACCESSORY. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. IT IS LIKELY THAT THE ACTUAL SAMPLE MET SOME OBJECT (E.G. HIGH FREQUENCY KNIFE) AND GOT A CRACK. SUBSEQUENTLY, WHEN IT WAS SUBJECTED TO TORQUE FORCE, IT BECAME FRACTURED FROM THE CRACK. IT IS LIKELY THAT THE EXFOLIATION OF PTFE COATING OCCURRED WHEN THE ACTUAL SAMPLE IN THE STATE OF HAVING BEEN EXPOSED TO A HARD OBJECT WAS MANIPULATED IN THE PROXIMAL DIRECTION. DUE TO THIS MANIPULATION, THE PTFE COATING WAS SUBJECTED TO EXCESSIVE ABRADING FORCE AND EXFOLIATED. SINCE THE PTFE COATING ON THE KINKED SECTION HAD BEEN EXFOLIATED, THE ACTUAL SAMPLE MAY HAVE BEEN SUBJECTED TO SOME BENDING FORCE AFTER EXPERIENCING ABRADING FORCE. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    LOT NUMBER: SUBJECTED LOTS: 200403, 200406, 200409, 200414, 200423, 200424, AND 200428. EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER; ESTIMATED DATE: 31MAY2023. UDI: NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER; ESTIMATED DATE: APRIL 2020 (B)(4). THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION, THE INVESTIGATION WILL RESUME WHEN THE INFECTIOUSNESS OF THE ACTUAL SAMPLE HAS BEEN CLARIFIED. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT RELEASE JUDGEMENT RECORD OF THE PRODUCT CODE/ SUBJECTED LOT#'S COMBINATIONS WERE CONDUCTED WITH NO FINDINGS. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE ACTUAL SINGLE USE GUIDEWIRE WAS USED IN COMBINATION WITH OLYMPUS KD-V451M (TRIPLE-LUMEN NEEDLE KNIFE) DURING THE PROCEDURE. WHEN THE NEEDLE KNIFE WAS USED WITH HIGH FREQUENCY OUTPUT, THE ACTUAL SAMPLE BROKE, AT APPROXIMATELY 10CM - 20CM FROM THE DISTAL END INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED. THE FRAGMENT WAS RETRIEVED WITH BIOPSY FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733168 SINGLE USE GUIDWIRE ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention KD-V451M