BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 16938066 · Received May 16, 2023

    Report

    Report Number
    9681834-2023-00093
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    April 20, 2023
    Report Date
    May 16, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K): K122590, K163004 VISUAL INSPECTION OF THE ACTUAL SAMPLE FOUND THAT THE OUTER LAYER HAD BEEN FLARED TOWARD THE DISTAL SIDE, AND THE WIRE HAD BEEN EXPOSED. PART OF THE OUTER LAYER HAD BEEN FLARED AND DEFORMED. EXPOSURE OF THE WIRE WAS OVER APPROXIMATELY 35MM. FLARE OF THE OUTER LAYER WAS OVER APPROXIMATELY 24MM (*). THE SECTION WHERE THE OUTER LAYER WAS FLARED AND DEFORMED DUALLY WAS APPROXIMATELY 4MM X 2 = APPROXIMATELY 8MM (*). THE TOTAL FLARED SECTION OF THE OUTER LAYER (*) WAS APPROXIMATELY 32MM, WITHOUT TAKING THE BUCKLED SECTION INTO ACCOUNT. MAGNIFYING INSPECTION OF THE ACTUAL SAMPLE FOUND THAT AT THE DEFORMED SECTION OF OUTER LAYER (APPROXIMATELY 30MM FROM THE DISTAL END), IT HAD BEEN BUCKLED AND THE OUTER LAYER HAD BEEN FRACTURED. AT APPROXIMATELY 55MM FROM THE DISTAL END, FLARED SECTION OF THE OUTER LAYER HAD BEEN TURNED BACK. AT APPROXIMATELY 90MM FROM THE DISTAL END, THE OUTER LAYER HAD BEEN FRACTURED. NO ANOMALY SUCH AS PEELING OF THE OUTER LAYER WAS FOUND IN OTHER SECTIONS. ELECTRON MICROSCOPIC INSPECTION OF THE ACTUAL SAMPLE FOUND THAT THERE WAS A TEAR DUE TO ELONGATION OF THE OUTER LAYER IN THE VICINITY OF DEFORMED SECTION ON THE OUTER LAYER. AT THE FLARED SECTION OF OUTER LAYER (APPROXIMATELY 35MM AND 38MM FROM THE DISTAL END), THE SURFACE HAD BEEN SCRATCHED. THE FRACTURE SURFACE OF OUTER LAYER, AT APPROXIMATELY 90MM FROM THE DISTAL END, WAS A MIXTURE OF SMOOTH AND TORN. MAGNIFYING INSPECTION OF THE ACTUAL SAMPLE FOR CONFIRMATION OF MISSING PART FOUND THAT THE BUCKLING ON THE DEFORMED SECTION OF ACTUAL SAMPLE WAS RELEASED, THE FLARED SECTION OF OUTER LAYER WAS RESTORED, AND IT WAS CONFIRMED WHETHER THERE WAS ANY MISSING PART IN THE ACTUAL SAMPLE. THE SHAPE ON THE FRACTURED SECTION OF OUTER LAYER AT APPROXIMATELY 90MM FROM THE DISTAL END AND THE FRACTURED SECTION OF OUTER LAYER FOUND AT THE DEFORMED SECTION WERE SIMILAR. THEREFORE, IT WAS INFERRED THAT THERE WAS NO MAJOR MISSING PART IN THE ACTUAL SAMPLE. HOWEVER, SINCE THE OUTER LAYER WAS GREATLY DEFORMED, AND IT WAS FOUND THAT THE OUTER LAYER WAS ELONGATED AND TORN, IT WAS NOT POSSIBLE TO CLARIFY IF SMALL PIECES WERE MISSING. ELECTRON MICROSCOPIC INSPECTION OF THE ACTUAL SAMPLE AFTER CONFIRMATION OF MISSING PART FOUND THAT IT WAS SCRATCHED IN THE VICINITY OF THE FRACTURED SECTION OF OUTER LAYER AT APPROXIMATELY 90MM FROM THE DISTAL END. THEREFORE, IT WAS INFERRED THAT IT CAME INTO CONTACT WITH SOME HARD OBJECT IN THE VICINITY OF THE FRACTURED SECTION OF OUTER LAYER. DIMENSION OF THE OUTER DIAMETER OF THE NORMAL SECTION MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE FOUND NO ANOMALY. NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER FROM OTHER FACILITIES WAS FOUND. SIMULATION TEST: FROM THE CONDITION OF ACTUAL SAMPLE AND THE CONTENTS OF REPORTED ISSUE, IT WAS INFERRED THAT THE INVOLVED SECTION WAS IN CONTACT WITH THE STENT STRUT PLACING IN THE ILIAC ARTERY, AND THE STENT STRUT WAS PULLED OUT IN A STUCK STATE WITH A STRONG FORCE, THEREBY PEELING THE OUTER LAYER. THEREFORE, THE FOLLOWING SIMULATION TEST WAS PERFORMED. A FACTORY-RETAINED STENT FOR ILIAC ARTERY (MISAGO) WAS PLACED IN THE TUBE. IN ORDER TO MAKE CONTACT WITH THE STENT STRUT, A FACTORY-RETAINED 0.035" GUIDEWIRE WAS PASSED THROUGH THE STENT STRUT AS IF THREADING IT, AND THEN PULLED OUT WITH STRONG FORCE. MAGNIFYING AND ELECTRON MICROSCOPIC INSPECTIONS OF THE SIMULATED PRODUCT FOUND NO PEELING OF THE OUTER LAYER WAS FOUND AT THE SECTION WHERE IT WAS IN CONTACT WITH THE STENT STRUT. SCRATCHES WERE SCATTERED AT THE SECTION WHERE IT WAS IN CONTACT WITH THE STENT STRUT. ALTHOUGH THE CONDITION OF SIMULATED PRODUCT WAS DIFFERENT FROM THAT OF THE ACTUAL SAMPLE, IT WAS FOUND THAT THE GUIDEWIRE STRONGLY CONTACTED THE STENT STRUT FOR THE ILIAC ARTERY, CAUSING SCRATCHES ON THE OUTER LAYER. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD, THE SHIPPING INSPECTION RECORD, AND THE DIMENSION OF THE ACTUAL SAMPLE. FROM THE CONDITION OF ACTUAL SAMPLE AND THE CONTENTS OF REPORTED ISSUE, IT WAS INFERRED THAT THE GUIDEWIRE GOT STUCK IN THE STENT STRUT PLACED IN THE ILIAC ARTERY FOR SOME REASON AND WAS PULLED OUT WITH STRONG FORCE IN THAT STATE. AS A RESULT, THE OUTER LAYER WAS FRACTURED AND FLARED. FROM THE SIMULATION TEST RESULT, ALTHOUGH THE CONTACT WITH A FACTORY-RETAINED STENT STRUT FOR ILIAC ARTERY DID NOT CAUSE PEELING OF THE OUTER LAYER, IT WAS INFERRED THAT THE STRONG CONTACT OF THE GUIDEWIRE WITH THE STENT STRUT CAUSED SCRATCH TO THE OUTER LAYER OF GUIDEWIRE, WHICH BECAME THE STARTING POINT FOR FRACTURE OF THE OUTER LAYER. IT WAS INFERRED THAT THERE WAS NO MAJOR MISSING PART IN THE ACTUAL SAMPLE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLLDEWIRE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE RADIFOCUS GUIDEWIRE WAS USED DURING AN ANGIOGRAPHY OF THE LOWER LIMB OF A PATIENT IN WHOM PALMAZ STENTS WERE PLACED IN THE LEFT AND RIGHT COMMON ILIAC ARTERIES. IT WAS REPORTED THAT WHEN THE WIRE WAS ADVANCED INTO THE RIGHT EXTERNAL ILIAC ARTERY, RESISTANCE WAS FELT. WHEN THE WIRE WAS ATTEMPTED TO BE PULLED OUT, THE PRODUCT GOT CAUGHT ON THE STENT STRUT AND COULD NOT BE PULLED OUT. AFTER USING FORCE MANY TIMES, THE WIRE WAS PULLED OUT. IT WAS ABLE TO BE REMOVED; HOWEVER, THE URETHANE WAS PEELING OFF. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED. IT WAS UNKNOWN IF THE PEELED URETHANE REMAINED IN THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1671230 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO MEDICAL CORPORATION N/A 220907

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown