BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO RADIFOCUS GUIDE WIRE

    MDR report key: 21798829 · Received April 8, 2025

    Report

    Report Number
    9681834-2025-00055
    Event Type
    Injury
    Date Received
    April 8, 2025
    Date of Event
    August 18, 2022
    Report Date
    April 8, 2025
    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

    D4: UDI: N/A AT THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. G4: 510(K): K926214. H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE INVOLVED LOT # WAS NOT PROVIDED. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED, INVESTIGATION OF IT COULD NOT BE PERFORMED. SINCE THE ACTUAL DEVICE WAS NOT RETURNED, INVESTIGATION OF IT COULD NOT BE PERFORMED. HISTORY INVESTIGATION OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER SINCE THE LOT# WAS UNKNOWN, THE MANUFACTURING RECORD AND SHIPPING INSPECTION RECORD COULD NOT BE INVESTIGATED. IN THE PAST TWO YEARS, WE HAVE NOT RECEIVED ANY SIMILAR COMPLAINTS OF THE INVOLVED PRODUCTS CAUSED BY THE MANUFACTURING PROCESS. CAUSE OF OCCURRENCE/CONCLUSION: SINCE THE LOT NUMBER WAS UNKNOWN, THE MANUFACTURING RECORD AND SHIPPING INSPECTION RECORD OF THE ACTUAL DEVICE COULD NOT BE INVESTIGATED. IN ADDITION, SINCE THE ACTUAL DEVICE WAS NOT RETURNED AND INVESTIGATION OF IT COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. 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 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 CORPORATION (TMC) (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

    LITERATURE REVIEW PERFORMED (K2405151) INVESTIGATION OF THE CASE USING RADIFOCUS GUIDE WIRE M. DAMAGE TO THE LEFT ATRIAL APPENDAGE (LAA). IT WAS FOUND DURING THE ATRIAL SEPTAL DEFECT (ASD) CREATION PROCEDURE THE DAY AFTER THE BALLOON ATRIAL SEPTOSTOMY (BAS). THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT IMPACT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739730 TERUMO RADIFOCUS GUIDE WIRE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RF-GA18153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other