BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 8768070 · Received July 8, 2019

    Report

    Report Number
    9681834-2019-00119
    Event Type
    Malfunction
    Date Received
    July 8, 2019
    Date of Event
    June 7, 2019
    Report Date
    July 8, 2019
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER - SECOND POTENTIAL LOT NUMBER: 181214; MANUFACTURER DATE: 14DEC2018; EXPIRATION DATE: 30NOV2020. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 510(K): K923607 AND K926214. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE URETHANE OUTER LAYER HAD BEEN SHEARED OFF ON APPROXIMATELY 22 - 115MM FROM THE DISTAL END OF THE DEVICE. MAGNIFYING INSPECTION OF THE URETHANE OUTER LAYER ON APPROXIMATELY 22 - 115MM FROM THE DISTAL END OF THE DEVICE OBTAINED THE FOLLOWING: AT APPROXIMATELY 22MM FROM THE DISTAL END OF THE DEVICE, THE OUTER LAYER HAD A CRACK; THE SHEAR CROSS-SECTION AT APPROXIMATELY 115MM FROM THE DISTAL END OF THE DEVICE HAD SMOOTH SURFACE; THE END OF THE SHEARED OUTER LAYER AT APPROX. 115MM FROM THE DISTAL END OF THE DEVICE WAS IN THE SHARP SHAPE. THE SHEARED SECTION OF THE URETHANE OUTER LAYER WAS PUT ALONG THE URETHANE OUTER LAYER SHEARED-SECTION OF THE WIRE UNDER MAGNIFICATION. THEY WERE FOUND TO MATCH EACH OTHER. FROM THIS IT IS MOST LIKELY THAT THERE IS NO FRAGMENT OF THE SHEARED URETHANE OUTER LAYER MISSING FROM THE WIRE OR REMAINING IN THE BODY. THE OUTSIDE DIAMETER OF THE UNDAMAGED SECTION WAS MEASURED AND CONFIRMED TO MEET THE SPECIFICATIONS. REPRODUCTIVE TESTING WAS PERFORMED A CURRENT GUIDEWIRE SAMPLE WAS INSERTED INTO A METAL NEEDLE AND WITHDRAWN FROM IT IN THE MANNER OF THE GUIDEWIRE SAMPLE HAVING CONTACT WITH THE METAL NEEDLE. THE URETHANE OUTER LAYER WAS SHEARED OFF FROM THE GUIDEWIRE SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT RELEASE DECISION CONTROL SHEETS OF THE PRODUCT CODE/ BOTH POTENTIAL LOT# COMBINATIONS WERE CONDUCTED WITH NO FINDINGS. IFU STATES: 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. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. IT IS LIKELY THAT WHEN THE ACTUAL DEVICE WAS INSERTED INTO THE VESSEL THROUGH THE COMPETITOR'S METAL NEEDLE, THE URETHANE OUTER LAYER OF THE ACTUAL DEVICE CAME INTO CONTACT WITH THE EDGE OF THE METAL NEEDLE. SUBSEQUENTLY, WHEN THE ACTUAL DEVICE WAS WITHDRAWN THROUGH THE METAL NEEDLE, ITS URETHANE OUTER LAYER TO BECANE SHEARED WITH THE DISTAL EDGE OF THE METAL NEEDLE. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PTCD IN (B)(6) 2019, THE ACTUAL RADIFOCUS GUIDEWIRE M WAS INSERTED INTO THE VESSEL THROUGH A COMPETITOR'S METAL NEEDLE. DURING THE ACTUAL SAMPLE'S MANIPULATION THROUGH THE METAL NEEDLE, THE URETHANE OUTER LAYER OF THE ACTUAL SAMPLE BECAME SHEARED AND REMAINED IN THE GALLBLADDER. IN (B)(6) 2019, THE PATIENT'S GALLBLADDER WAS EXTRACTED; THIS PROCEDURE HAD NOTHING TO DO WITH THE REMAINING FRAGMENT OF THE OUTER LAYER OF THE ACTUAL SAMPLE, AND NO PIECE WAS LEFT IN THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561420 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 181122

    Patients

    Seq Age Sex Outcome Treatment
    1 METAL NEEDLE| PTC NEEDLE B-TYPE 18GX150MM/HAKKO