BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 14191215 · Received April 24, 2022

    Report

    Report Number
    9681834-2022-00075
    Event Type
    Injury
    Date Received
    April 24, 2022
    Date of Event
    December 10, 2021
    Report Date
    April 24, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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: DISTRIBUTOR. PMA/510(K)- K923607,K926214. DEVICE MANUFACTURER DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL DEVICE WAS NOT AVAILABLE FOR ANALYSIS. REVIEW OF MANUFACTURING HISTORY RECORDS COULD NOT BE PERFORMED SINCE THE INVOLVED LOT NUMBER WAS UNKNOWN. SIMULATION TEST/MECHANISM OF GUIDEWIRE FRACTURE: IT IS KNOWN FROM OUR PAST EXPERIMENTS THAT THE GUIDEWIRE MAY GET FRACTURED WHEN IT HAS BEEN SUBJECTED TO ONE OF THE LOADS DESCRIBED BELOW, IN ADDITION, AS FOR THE CORE WIRE, THE STATE OF THE FRACTURED END PRESENTS SOME REGULARITY DEPENDING ON THE FRACTURE MECHANISM AS FOLLOWS. (1) REPETITIVE BENDING LOAD AT A 90-DEGREE ANGLE. THE FRACTURED ENDS ARE NOT CURVED OR DEFORMED IN TAPER SHAPE, BUT DIMPLE PATTERN IS OBSERVED ON THE FRACTURE SURFACE. (2) CONTINUOUS ONE-WAY TORQUE LOAD TO A TEST SAMPLE KEPT IN A CURVE SHAPE. THE FRACTURED ENDS ARE NOT CURVED OR DEFORMED IN TAPER SHAPE, BUT RADIAL PATTERN IS OBSERVED ON THE FRACTURE SURFACE. (3) ONE-WAY PULLING LOAD. THE FRACTURED ENDS HAVE BEEN DEFORMED IN TAPER SHAPE. (4) PULLING LOAD TO A LOOP-SHAPED TEST SAMPLE. THE FRACTURED ENDS HAVE BEEN DEFORMED IN TAPER SHAPE AND CURVED. BASED ON THE PROVIDED INFORMATION IT WAS PRESUMED THAT THE ACTUAL DEVICE MIGHT HAVE BEEN EXPOSED TO ONE OF THE LOADS DESCRIBED IN SIMULATION TEST/MECHANISM OF GUIDEWIRE FRACTURE, WHICH RESULTED IN THE FRACTURE. HOWEVER, THE DEFINITE CAUSE OF OCCURRENCE COULD NOT BE DETERMINED BECAUSE THE ACTUAL DEVICE WAS NOT RETURNED, AND ANALYSIS COULD NOT BE PERFORMED. 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." (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE RADIFOCUS GLIDEWIRE M WAS FRACTURED DURING LAPAROSCOPIC SURGERY. A PART OF THE GUIDEWIRE WAS LEFT INSIDE THE HUMAN BODY. THE FRACTURED GUIDEWIRE WAS TAKEN OUT IN THE FOLLOWING PERCUTANEOUS CORONARY INTERVENTION (PCI), AND THE PATIENT WAS DISCHARGED SAFELY. THE PROCEDURE OUTCOME WAS NOT REPORTED. AFTER THE DEVICE WAS REMOVED THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183878 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O