BEUDAMED
    FDA Adverse Event Death Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 15192896 · Received August 9, 2022

    Report

    Report Number
    9681834-2022-00158
    Event Type
    Death
    Date Received
    August 9, 2022
    Date of Event
    July 7, 2022
    Report Date
    August 9, 2022
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER - REQUESTED, NOT PROVIDED. EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. UDI - N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. OCCUPATION - CLINICAL ENGINEER. 510(K) NO: K926214. MANUFACTURE DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL SAMPLE WAS DISCARDED THEREFORE THE ANALYSIS OF IT COULD NOT BE PERFORMED. IT IS KNOWN FROM OUR PAST SIMULATION TESTS THAT THE GUIDEWIRE MAY GET FRACTURED WHEN IT HAS BEEN SUBJECTED TO ONE OF THE FORCES DESCRIBED BELOW. IN ADDITION, THE STATE OF THE ENDS OF FRACTURED CORE WIRE PRESENTS SOME REGULARITY DEPENDING ON THE MECHANISM OF THE FRACTURE. REPEATED BENDING FORCE AT A 90-DEGREE ANGLE. THE FRACTURE ENDS ARE NOT DEFORMED IN TAPER SHAPE AND DIMPLE (HOLE-SHAPE) PATTERN IS OBSERVED ON THE FRACTURE SURFACE. CONTINUOUS ONE-WAY TORQUE FORCE TO A BENT WIRE. THE FRACTURE ENDS ARE NOT DEFORMED IN A TAPER SHAPE AND RADIAL PATTERN IS OBSERVED ON THE FRACTURE SURFACE. ONE-WAY PULLING FORCE. THE FRACTURE ENDS BECOME DEFORMED IN TAPER SHAPE. PULLING FORCE TO A LOOPED WIRE. THE FRACTURE ENDS BECOME CURVED AND DEFORMED IN TAPER SHAPE. SINCE THE INVOLVED LOT NUMBER WAS UNKNOWN, REVIEW OF THE MANUFACTURING-RELATED RECORDS COULD NOT BE PERFORMED. SINCE THE INVOLVED LOT NUMBER WAS UNKNOWN, A SEARCH OF THE COMPLAINT FILE COULD NOT BE PERFORMED. BASED ON OUR PAST FINDINGS, IT WAS PRESUMED THAT THE GUIDEWIRE MIGHT HAVE BEEN FRACTURED DUE TO HAVING BEEN EXPOSED TO ONE OF THE FORCES DESCRIBED ABOVE. MECHANISM OF THE FRACTURE OF GUIDEWIRE, HOWEVER, SINCE THE ACTUAL SAMPLE WAS NOT RETURNED AND THE ANALYSIS OF IT COULD NOT BE PERFORMED, THE CAUSE OF OCCURRENCE COULD NOT BE IDENTIFIED. 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." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE PATIENT WAS TAKEN TO THE FACILITY IN A STATE OF SHOCK DUE TO AORTIC DISSECTION. IN ORDER TO PERFORM DRAINAGE FOR PERICARDIAL TAMPONADE, PUNCTURE WAS DONE WITH HAPPYCATH FROM MEDIKIT AND THE GUIDEWIRE WAS INSERTED THROUGH THE CANNULA, HOWEVER, IT COULD NOT REACH TO THE TARGET REGION, SO IT WAS REMOVED. AFTER THE PATIENT WAS CONFIRMED DEAD DUE TO BLEEDING, CT SCAN WAS TAKEN AND SOMETHING LIKE A WIRE WAS OBSERVED IN THE IMAGE. THEN, THE GUIDEWIRE THAT HAD BEEN REMOVED FROM THE PATIENT WAS EXAMINED AND FOUND SHORTER THAN THE PROPER LENGTH, WHICH INDICATED THAT THE GUIDEWIRE HAD BEEN FRACTURED. NO EXTRACTION OR OTHER ACTION WAS TAKEN SINCE THE PATIENT HAD DIED. THERE WAS NO CAUSAL LINK BETWEEN THE PATIENT'S DEATH AND THE FRACTURE OF THE GUIDEWIRE IN THIS CASE. THE GUIDEWIRE WAS FRACTURED AND LEFT IN THE BODY. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254095 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| O HAPPYCATH - MEDIKIT