BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE

    MDR report key: 18410611 · Received December 28, 2023

    Report

    Report Number
    9681834-2023-00265
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    December 2, 2023
    Report Date
    December 28, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K863138
    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): K926214, K923607. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION; HOWEVER, A PHOTOGRAPH OF THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. THE PROVIDED PICTURE OF THE ACTUAL SAMPLE WAS CONFIRMED. IT WAS FOUND THAT A PART OF THE OUTER LAYER WAS PEELED OFF. FROM THE ADDITIONAL INFORMATION, IT WAS CONFIRMED THAT A METAL NEEDLE WAS USED IN COMBINATION. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO OTHER SIMILAR REPORT FROM OTHER FACILITIES WAS FOUND IN THE PAST COMPLAINT RECORD. BASED ON PAST FINDINGS, WE ARE AWARE THAT THE OUTER LAYER MAY BE PEELED OFF WHEN THE RADIFOCUS GUIDEWIRE M IS USED IN COMBINATION WITH A METAL NEEDLE. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. FROM THE CIRCUMSTANCES OF THE OCCURRENCE OF THIS CASE, IT WAS CONSIDERED POSSIBLE THAT THE OUTER LAYER OF THE ACTUAL SAMPLE WAS PEELED OFF SINCE THE ACTUAL SAMPLE AND A METAL NEEDLE WERE USED IN COMBINATION. HOWEVER, SINCE THE ACTUAL SAMPLE 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: "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. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Additional Manufacturer Narrative · 0

    THE PRODUCT CODE WAS NOT EXPORTED TO THE US MARKET; THEREFORE, THE UDI COULD NOT BE PROVIDED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE URETHANE MAY HAVE PEELED APPROXIMATELY TEN (10) CM FROM THE DISTAL END OF RADIFOCUS GUIDEWIRE. A METAL NEEDLE WAS USED, AND THE USER WAS AWARE OF THE CONTRAINDICATION. IMAGES WERE REVIEWED; HOWEVER, NO FRACTURED PIECE COULD BE FOUND. THERE WAS A POSSIBILITY THAT IT REMAINED IN THE BODY, HOWEVER IT WAS UNCLEAR. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1489901 RADIFOCUS GUIDEWIRE WIRE, GUIDE, CATHETER DQX TERUMO MEDICAL CORPORATION N/A 230116YA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown METAL NEEDLE