BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 10821692 · Received November 11, 2020

    Report

    Report Number
    9681834-2020-00226
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Date of Event
    October 15, 2020
    Report Date
    November 11, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI NOT REQUIRED FOR PRODUCT CODE; IMPLANTED DATE: DEVICE WAS NOT IMPLANTED; EXPLANTED DATE: DEVICE WAS NOT EXPLANTED; PMA/510(K): K926214. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE ACTUAL SAMPLE HAD BEEN BROKEN AT APPROXIMATELY 70 MM FROM THE DISTAL END AND DIVIDED INTO TWO PORTIONS. THE TOTAL LENGTH OF THE ACTUAL SAMPLE WAS MEASURED, AND CONFIRMED TO BE EQUIVALENT TO THAT OF A RETENTION SAMPLE FROM THE SAME PRODUCT CODE. FROM THIS, IT WAS JUDGED THAT THE ACTUAL SAMPLE HAD NO MISSING PORTION. DISTAL PORTION (FRAGMENT): 70 MM IN LENGTH, PROXIMAL PORTION (MAIN BODY): 2530 MM IN LENGTH, TOTAL LENGTH OF THE ACTUAL SAMPLE: 2600 MM (RETENTION SAMPLE: 2600 MM). MAGNIFYING INSPECTION OF THE DISTAL PORTION (FRAGMENT) REVEALED THAT THE URETHANE COATING AT THE PROXIMAL END SEEMED TO HAVE BEEN TORN-OFF, AND THE URETHANE COATING AT THE PROXIMAL END HAD BEEN ELONGATED. ELECTRON MICROSCOPIC INSPECTION OF THE DISTAL PORTION (FRAGMENT) REVEALED SOME CREASES NEAR THE PROXIMAL END, AND A SCRATCH WAS OBSERVED ON THE URETHANE COATING NEAR THE PROXIMAL END. MAGNIFYING INSPECTION OF THE PROXIMAL PORTION (MAIN BODY) REVEALED THAT THE CORE WIRE WAS EXPOSED FROM THE DISTAL END, AND THE URETHANE COATING AT THE DISTAL END HAD BEEN ELONGATED. ELECTRON MICROSCOPIC INSPECTION OF THE PROXIMAL PORTION (MAIN BODY) REVEALED SOME CREASES ON THE URETHANE COTING NEAR THE DISTAL END. ELECTRON MICROSCOPIC INSPECTION OF THE CROSS SECTION REVEALED RADIAL PATTERN ON THE SURFACE OF BOTH PORTIONS. NO TAPERED DEFORMATION WAS OBSERVED IN EITHER ENDS. THE OUTER DIAMETER OF THE ACTUAL SAMPLE WAS MEASURED AND CONFIRMED TO MEET THE FACTORY'S CONTROL CRITERIA. REPRODUCTIVE TESTING WAS PERFORMED. TORQUE LOAD IN ONE DIRECTION CONSECUTIVELY TO THE TEST SAMPLE KEPT IN A CURVED SHAPE. THE FRACTURE CROSS SECTION IS FLAT AND RADIAL PATTERN IS OBSERVED ON THE FRACTURE SURFACE. SINCE THIS STATE IS SIMILAR TO THAT OBSERVED ON THE ACTUAL SAMPLE, IT WAS CONCEIVABLE THAT THE ACTUAL SAMPLE WAS FRACTURED DUE TO THE SAME FRACTURE MECHANISM. REPETITIVE BENDING LOAD AT A 90-DEGREE ANGLE. DIMPLE PATTERN IS OBSERVED ON THE FRACTURE SURFACE. THE FRACTURE CROSS SECTION IS ALMOST FLAT AND DIMPLE PATTERN WAS OBSERVED. THIS STATE IS DIFFERENT FROM THAT OBSERVED ON THE ACTUAL SAMPLE. PULLING LOAD TO THE TEST SAMPLE KEPT IN A LOOP SHAPE. THE FRACTURE END HAS BEEN CURVED, AND THE CROSS SECTION IS ROUGH. THIS STATE IS DIFFERENT FROM THAT OBSERVED ON THE ACTUAL SAMPLE. PULLING LOAD IN ONE DIRECTION. THE OUTSIDE DIAMETER OF THE CORE WIRE HAS BEEN DIMINISHED TOWARD THE FRACTURE END. THIS STATE IS DIFFERENT FROM THAT OBSERVED ON THE ACTUAL SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. IFU STATES: IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GUIDE WIRE M AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. CONTINUING TO MANIPULATE, OR ROTATE THE GUIDE WIRE M OR FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDE WIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE VESSEL. DO NOT APPLY REPETITIVE BENDING FORCE TO ONE SPECIFIC POINT OF THE DEVICE AS THIS MAY CAUSE DAMAGE TO THE GUIDE WIRE M. 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 WAS SUBJECTED TO AN EXCESSIVE TORQUE LOAD WHILE IT WAS KEPT IN A CURVED SHAPE. AS A RESULT, THE CORE WIRE WAS FRACTURED DUE TO METAL FATIGUE, AND SUBSEQUENTLY, THE URETHANE LAYER WAS RIPPED WHEN THE ACTUAL SAMPLE WAS MANIPULATED OR WITHDRAWN. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS GUIDEWIRE M WAS USED DURING THE PROCEDURE. ERCP IN GASTROENTEROLOGY DEPT. THE ACTUAL SAMPLE WAS USED IN COMBINATION WITH AN ENDOSCOPE FOR A PATIENT WITH BILE DUCT DISRUPTION. AFTER THE PROCEDURE WAS COMPLETED, THE ACTUAL SAMPLE BROKE IN TWO AT 15 CM FROM THE DISTAL END WHILE IT WAS OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION RECEIVED ON 22OCT2020. PANCREATIC DUCT IMAGING WAS PERFORMED WITH THE TIP OF THE ACTUAL SAMPLE PROTRUDING FROM AN ANGIOGRAPHIC CATHETER (UNKNOWN TYPE/BRAND). WHEN THE OPERATOR MANIPULATED THE ACTUAL SAMPLE, THE TIP WOULD NOT MOVE. THE OPERATOR THOUGHT A PROBLEM HAPPENED, AND TOOK THE ACTUAL SAMPLE OUT FROM THE PATIENT. THE ACTUAL SAMPLE BROKE IN TWO PORTIONS OUTSIDE THE PATIENT. IT WAS JUDGED THAT THERE WAS NO HARM TO THE PATIENT HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287731 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 200622

    Patients

    Seq Age Sex Outcome Treatment
    1