BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 13075062 · Received December 23, 2021

    Report

    Report Number
    9681834-2021-00239
    Event Type
    Injury
    Date Received
    December 23, 2021
    Date of Event
    November 29, 2021
    Report Date
    December 23, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K)- K923607, K926214. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE ACTUAL SAMPLE HAD BEEN FRACTURED AT APPROXIMATELY 10MM FROM THE DISTAL END. THE TOTAL LENGTH OF ACTUAL SAMPLE WAS APPROXIMATELY 1000MM. SINCE THE NORMAL PRODUCT WAS APPROXIMATELY 1000MM, IT WAS INFERRED THAT THERE WAS NO MISSING PIECE IN THE ACTUAL SAMPLE. MAGNIFYING INSPECTION OF THE ACTUAL SAMPLE REVEALED THAT THE WIRE WAS EXPOSED AT BOTH THE FRACTURED SECTION ON THE DISTAL SIDE AND THE REAR END SIDE. A PART OF THE OUTER LAYER OF THE FRACTURED SECTION ON THE DISTAL SIDE HAD BEEN ELONGATED. ELECTRON MICROSCOPIC INSPECTION OF THE ACTUAL SAMPLE REVEALED WRINKLES AND TORN SHAPES WERE FOUND IN THE OUTER LAYER AT BOTH THE FRACTURED SECTION ON THE DISTAL SIDE AND THE REAR END SIDE. THE OUTER DIAMETER OF ACTUAL SAMPLE IN THE VICINITY OF FRACTURED SECTION WAS MEASURED AND CONFIRMED TO MEET THE SPECIFICATIONS. THE OUTER LAYER OF ACTUAL SAMPLE WAS REMOVED, AND ELECTRON MICROSCOPIC INSPECTION WAS PERFORMED TO CONFIRM THE WIRE. FOLLOWING RESULTS WERE OBTAINED: THE SHAPES OF FRACTURED SECTION OF WIRE ON THE DISTAL SIDE AND THE REAR END SIDE WERE MATCHED. NO TAPERING WAS FOUND. A DIMPLE PATTERN (A HOLE-SHAPED PATTERN) WAS FOUND ON BOTH THE FRACTURED SURFACE OF THE WIRE ON THE DISTAL SIDE AND THE REAR END SIDE. SIMULATION TEST: THE FOLLOWING SIMULATION TEST WAS PERFORMED FOR THE FRACTURE OF GUIDEWIRE, AND IT WAS CONFIRMED THAT THE WIRE STATE HAS REGULARITY DEPENDING ON THE MECHANISM LEADING TO THE FRACTURE. REPEATED BENDING FORCE WAS APPLIED. 90 ° FOLDED BENDING FORCE WAS REPEATEDLY APPLIED UNTIL FRACTURE OCCURRED. THE FRACTURED SECTION OF WIRE WAS NOT TAPERED, AND A DIMPLE PATTERN (A HOLE-SHAPED PATTERN) WAS FORMED ON THE FRACTURED SURFACE, WHICH WAS SIMILAR TO THE ACTUAL SAMPLE. CONTINUOUS TORQUE FORCE WAS APPLIED IN THE SAME DIRECTION WHILE THE GUIDEWIRE WAS CURVED. CONTINUOUS TORQUE FORCE WAS APPLIED IN THE SAME DIRECTION UNTIL FRACTURE OCCURRED. THE FRACTURED SECTION OF WIRE WAS NOT TAPERED, WAS FLAT, AND A RADIAL PATTERN WAS FORMED ON THE FRACTURED SURFACE. IT WAS INFERRED THAT THE MECHANISM OF OCCURRENCE WAS DIFFERENT FROM THE ACTUAL SAMPLE. PULLING FORCE WAS APPLIED. PULLING FORCE WAS APPLIED IN THE SAME DIRECTION UNTIL FRACTURE OCCURRED. THE FRACTURED SECTION OF WIRE WAS TAPERED. IT WAS INFERRED THAT THE MECHANISM OF OCCURRENCE WAS DIFFERENT FROM THE ACTUAL SAMPLE. PULLING FORCE WAS APPLIED IN A LOOPED STATE. PULLING FORCE WAS APPLIED IN A LOOPED STATE UNTIL FRACTURE OCCURRED. THE FRACTURED SECTION OF WIRE WAS CURVED AND TAPERED, AND THE FRACTURED SURFACE WAS ROUGH. IT WAS INFERRED THAT THE MECHANISM OF OCCURRENCE WAS DIFFERENT FROM THE ACTUAL SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED 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 GLIDEWIRE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. 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. 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 WAS LIKELY THAT WHEN ATTEMPTED TO PASS THROUGH THE LESION, REPEATED BENDING FORCE WAS APPLIED AT A POSITION APPROX. 10MM FROM THE DISTAL END OF ACTUAL SAMPLE AND WAS FRACTURED DUE TO METAL FATIGUE. SINCE THE TOTAL LENGTH OF ACTUAL SAMPLE WAS THE SAME AS THAT OF THE NORMAL PRODUCT AND THE SHAPE OF FRACTURED SECTION OF THE WIRE WERE THE SAME ON THE DISTAL SIDE AND THE REAR END SIDE, THERE WAS NO MISSING PIECE IN THE ACTUAL SAMPLE. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE RADIFOCUS GUIDEWIRE M WAS USED DURING THE PROCEDURE. THE SHUNT PTA WAS PERFORMED BY PUNCTURING THE LEFT RADIAL ARTERY. THIS PRODUCT WAS ADVANCED USING THE GOODTEC 4FR 3CM SHEATH. HOWEVER, SINCE THE LESION WAS HARD, IT WAS NOT ADVANCED EASILY, AND THE WIRE WAS KNUCKLED. SO, WHEN STERLING 5.0-40 BALLOON WAS USED TOGETHER AND ADVANCED AGAIN, THE WIRE BECAME STRAIGHT AND COULD BE ADVANCED A LITTLE. HOWEVER, IT DID NOT REACH THE TARGET SITE. EVEN THOUGH TORQUE FORCE WAS APPLIED, IT WAS UNSUCCESSFUL. THEN, ANGIOGRAPHY WAS PERFORMED TO CONFIRM, AND IT WAS FOUND THAT THE DISTAL END OF WIRE REMAINED IN THE PATIENT'S BODY. THE BALLOON AND THIS PRODUCT WERE REMOVED, AND WITH THE CONSENT OF THE PATIENT, AN INCISION WAS MADE AND THE DISTAL END OF IT WAS REMOVED. IT WAS APPROXIMATELY 5 - 10MM. THE SHUNT PTA ENDED THERE. THE PATIENT'S CONDITION WAS FINE, SO THEY DECIDED TO PERFORM A SURGICAL CONSTRUCTION OF SHUNT. THE PATIENT HAD MINOR HARM BUT DID NOT HAVE SERIOUS INJURY. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1979422 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 210726

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention GOODTEC SHEATH| STERLING BALLOON