BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 8150020 · Received December 11, 2018

    Report

    Report Number
    9681834-2018-00223
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    November 20, 2018
    Report Date
    December 11, 2018
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510(K): K923607 AND K926214 H6: PATIENT CODE: 3191: SEPARATED PIECE OF ACTUAL SAMPLE WAS IN PATIENT; HOWEVER, IT WAS SURGICALLY REMOVED H6 - RESULTS - 3252 IS BASED ON EVALUATION OF USER FACILITY INFORMATION & THE RETURNED SAMPLE; 213 IS BASED UPON EVALUATION OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE. H6 - CONCLUSION - 4310 IS BASED UPON EVALUATION OF USER FACILITY INFORMATION & THE RETURNED SAMPLE; 67 IS BASED UPON EVALUATION OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE. THE ACTUAL DEVICE AND THE METAL NEEDLE THAT WAS USED IN COMBINATION WITH THE ACTUAL DEVICE WERE RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE ACTUAL DEVICE UPON RECEIPT REVEALED THAT THE URETHANE OUTER LAYER HAD BEEN SHEARED OFF ON APPROXIMATELY 40 - 184MM FROM THE DISTAL END OF THE DEVICE. MAGNIFYING INSPECTION OF THE URETHANE OUTER LAYER SHEARED SEGMENT OBTAINED THE FOLLOWING. ON APPROXIMATELY 40 - 60MM FROM THE DISTAL END OF THE DEVICE, THE URETHANE OUTER LAYER HAD BEEN SHEARED OFF PARTIALLY WITH NO EXPOSURE OF THE CORE WIRE. ON APPROXIMATELY 60 - 108MM AND 105 - 184MM FROM THE DISTAL END OF THE DEVICE, THE URETHANE OUTER LAYER HAD BEEN SEMI-CIRCUMFERENTIALLY SHEARED OFF, WHERE THE CORE WIRE WAS EXPOSED. THE SHEAR CROSS-SECTIONS OF THE URETHANE OUTER LAYER WERE IN THE SMOOTH STATE. THE OUTSIDE DIAMETER WAS MEASURED ON THE UNDAMAGED SEGMENT AND CONFIRMED TO MEET MANUFACTURER SPECIFICATIONS. VISUAL INSPECTION OF THE METAL NEEDLE UPON RECEIPT REVEALED NO DEFECTS. FUNCTIONAL TESTING WAS CONDUCTED. A CURRENT GUIDEWIRE PRODUCT SAMPLE WAS INSERTED INTO A METAL NEEDLE AND WITHDRAWN FROM IT IN THE MANNER OF THE GUIDEWIRE SAMPLE HAVING CONTACT WITH THE METAL NEEDLE.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. THE SURFACE OF THE SHEAR CROSS-SECTION OF THE URETHANE OUTER LAYER WAS FOUND TO BE IN THE SMOOTH STATE, SIMILAR TO THAT OF THE ACTUAL SAMPLE. A REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT /LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. THE IFU STATES: " DO NOT MANIPULATE OR WITHDRAW THE GUIDE WIRE M 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." THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE INVESTIGATION, IT IS LIKELY THAT THE ACTUAL DEVICE WAS SUBJECTED TO A WITHDRAWAL MANIPULATION IN THE STATE WHERE ITS URETHANE OUTER LAYER HAD CONTACT WITH THE METAL NEEDLE USED IN COMBINATION WITH THE ACTUAL DEVICE. AS THE RESULT, THE URETHANE OUTER LAYER GOT SHEARED OFF THE WIRE. 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 SEPARATION OF THE URETHANE LAYER ON THE INVOLVED RADIFOCUS GUIDEWIRE M. DURING THE PROCEDURE TO IMPLANT AN INJECTION PORT FOR LONG-TIME-USE, THE ACTUAL SAMPLE WAS USED IN COMBINATION WITH A METAL NEEDLE. WHILE THE ACTUAL SAMPLE WAS BEING WITHDRAWN THROUGH THE METAL NEEDLE, THE URETHANE OUTER LAYER WAS SHEARED OFF AND REMAINED IN THE PATIENT'S BODY. THE SHEARED SEGMENT WAS COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE OUTCOME IS UNKNOWN. THE CURRENT PATIENT CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993509 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 180416

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention POWERPORT® IMPLANTABLE PORT| POWERPORT® IMPLANTABLE PORT