BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 17755518 · Received September 15, 2023

    Report

    Report Number
    9681834-2023-00182
    Event Type
    Injury
    Date Received
    September 15, 2023
    Date of Event
    August 16, 2023
    Report Date
    September 15, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    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 AS 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: PMA/510(K): K923607, K926214. 1. INVESTIGATION OF THE ACTUAL SAMPLE: SINCE THE ACTUAL SAMPLE WAS NOT RETURNED, INVESTIGATION OF IT COULD NOT BE PERFORMED. 2. HISTORY INVESTIGATION: REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT NUMBER CONFIRMED THAT THERE WAS NOT ANY ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION FROM OTHER FACILITIES. 3. CAUSE OF OCCURRENCE/CONCLUSION: BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. HOWEVER, SINCE THE ACTUAL SAMPLE WAS NOT RETURNED AND INVESTIGATION COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO IDENTIFY 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 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 DURING A PROCEDURE USING THE RADIFOCUS GUIDEWIRE, THE TIP OF THE RADIFOCUS GUIDEWIRE BROKE AND REMAINED IN THE BLOOD VESSEL. IT WAS RETRIEVED OUTSIDE THE BODY WITH A SNARE WITH NO HEALTH HAZARDOUS OUTCOME. NO RESIDUES LEFT IN THE BODY AS IT WAS ABLE TO BE RETRIEVED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315248 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO MEDICAL CORPORATION N/A 230127YA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention