BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS INTRODUCER II.H 8.5F

    MDR report key: 16380851 · Received February 15, 2023

    Report

    Report Number
    9681834-2023-00026
    Event Type
    Injury
    Date Received
    February 15, 2023
    Report Date
    February 15, 2023
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K071494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. PRODUCT CODE: UNKNOWN. LOT NUMBER UNKNOWN. EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN PRODUCT CODE AND LOT NUMBER. UDI: THIS IS THE PRODUCT CODE THAT IS NOT REQUIRED TO BE REGISTERED WITH FDA. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. CONTACT NUMBER: UNKNOWN. ADDRESS: UNKNOWN. PHONE NUMBER: UNKNOWN. HEALTHCARE PROFESSIONAL: UNKNOWN. OCCUPATION: UNKNOWN. 510K: K130520. DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN PRODUCT CODE AND LOT NUMBER. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED, DETAILED INVESTIGATION COULD NOT BE PERFORMED. REVIEW OF THE MANUFACTURING HISTORY RECORD AND THE PRODUCT INSPECTION RECORD COULD NOT BE CARRIED OUT SINCE THE INVOLVED PRODUCT CODE/LOT NUMBER WAS UNKNOWN. AS THE INVOLVED PRODUCT NAME WAS REPORTED AS "RADIFOCUS INTRODUCER II.H 8.5F", PAST COMPLAINTS FOR THE SAME WAS REVIEWED. THERE WAS NO SIMILAR EVENT IN WHICH GLIDESHEATH II.H 8.5F WAS INVOLVED IN THE PAST TWO YEARS. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED AND ITS CONDITION COULD NOT BE CONFIRMED, THE CAUSE OF THE OCCURRENCE COULD NOT BE CLARIFIED FROM THE INVESTIGATION RESULT. IFU STATES: "PRECAUTIONS 16ST DOT: DO NOT SCRATCH THE SHEATH WITH NEEDLE POINT , CUTTING TOOL , OR OTHER EDGED TOOLS." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO CORRECT SECTION D3.

    Description of Event or Problem · 0

    THE USER FACILITY REPORT THAT UNKNOWN RADIFOCUS INTRODUCER II.H 8.5F SHEATH BROKE AND REMAINED IN BLOOD VESSEL DURING ABLATION. AFTER A PUNCTURE TO PERFORM AN ABLATION FOR ATRIAL FIBRILLATION, AN 8.5FR SHEATH BROKE DURING INSERTION AND REMAINED IN THE BLOOD VESSEL. A CARDIOVASCULAR SURGEON INTERVENED AND INSERTED A SNARE THROUGH THE JUGULAR VEIN TO RETRIEVE THE REMAINING PIECE. THE USE OF THIS SHEATH WAS DISCONTINUED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126071 RADIFOCUS INTRODUCER II.H 8.5F ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY DYB TERUMO CORPORATION, ASHITAKA N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention