BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 17008125 · Received May 25, 2023

    Report

    Report Number
    9681834-2023-00096
    Event Type
    Injury
    Date Received
    May 25, 2023
    Date of Event
    April 28, 2023
    Report Date
    May 25, 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): NO: K863138, K923607, K926214. THE ACTUAL SAMPLE WAS NOT RETURNED, INVESTIGATION OF IT COULD NOT BE PERFORMED. HISTORY INVESTIGATION OF THE INVOLVED PRODUCT CODE/LOT NUMBER. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO OTHER SIMILAR REPORT FROM OTHER FACILITIES WAS FOUND. KNOWN MECHANISM OF PEELING OF OUTER LAYER BASED ON PAST FINDINGS, WE ARE AWARE THAT THE OUTER LAYER OF RADIFOCUS GUIDEWIRE M MAY BE PEELED OFF WHEN IT IS USED IN COMBINATION WITH A METAL NEEDLE. FROM THE INVESTIGATION RESULTS, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORDS AND SHIPPING INSPECTION RECORDS OF THE ACTUAL SAMPLE. IN THIS CASE, AS ONE OF THE POSSIBILITIES BASED ON THE CIRCUMSTANCES OF THE OCCURRENCE, IT WAS INFERRED THAT, WHEN THE ACTUAL SAMPLE WHILE BEING USED IN COMBINATION WITH A METAL NEEDLE WAS MANIPULATED IN THE WITHDRAWAL DIRECTION, THE OUTER LAYER CAME INTO CONTACT WITH THE METAL NEEDLE AND PEELED OFF. HOWEVER, SINCE THE ACTUAL SAMPLE WAS NOT RETURNED AND ANALYSIS COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: DO NOT MANIPULATE OR WITHDRAW THE GLIDEWIRE THROUGH A METAL ENTRY NEEDLE OR A METAL DILATOR. MANIPULATION AND/OR WITHDRAWAL THROUGH A METAL ENTRY NEEDLE OR A METAL DILATOR MAY RESULT IN DESTRUCTION AND/OR SEPARATION OF THE OUTER POLYURETHANE COATING REQUIRING RETRIEVAL. A PLASTIC ENTRY NEEDLE IS RECOMMENDED WHEN USING THIS WIRE FOR INITIAL PLACEMENT. 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 INVOLVED PATIENT HAD AN EMERGENCY AORTIC RUPTURE SURGERY, A NON-METALLIC NEEDLE WAS INITIALLY USED, BUT DUE TO DIFFICULTY IN INTRODUCING THE GUIDEWIRE, A METALLIC NEEDLE WAS USED. UPON CHECKING THE GUIDEWIRE, A TEAR OF 7MM TO 8MM WAS OBSERVED TO HAVE BEEN SCRAPPED. THE GUIDEWIRE IN QUESTION PEELED AND WAS LEFT BEHIND IN THE PULMONARY ARTERY. THE PATIENT'S CONDITION WAS STABLE WITH NO ACUTE HEALTH PROBLEMS. THE PATIENT IS UNDER OBSERVATION AND HAS NO RETRIEVAL INTERVENTION PLANNED. AS OF (B)(6) 2023, DETAILS OF THE INVOLVED DEPARTMENT, PROCEDURE, AND CONCURRENTLY USED DEVICES ARE UNKNOWN. THE EVENT OCCURRED INTRA-OPERATIVE. THE FINAL PATIENT IMPACT WAS HARMED BUT NOT SERIOUSLY. PEELED PIECE REMAINS IN THE PATIENT BODY (NOT RETRIEVABLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915925 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO MEDICAL CORPORATION N/A 220824

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other