BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS INTRODUCER

    MDR report key: 13313615 · Received January 21, 2022

    Report

    Report Number
    9681834-2022-00001
    Event Type
    Malfunction
    Date Received
    January 21, 2022
    Date of Event
    December 27, 2021
    Report Date
    January 21, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K033681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K)- K062858, K082644. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. IFU STATES: DO NOT SCRATCH THE SHEATH WITH NEEDLE POINT, CUTTING TOOL, OR OTHER EDGED TOOLS. AS A RESULT OF INVESTIGATING THE INFORMATION FOR THE PAST THREE YEARS, SEVERAL CASES FOR PINHOLES IN THE SHEATH TUBE IN RADIFOCUS INTRODUCER II H WERE FOUND. HOWEVER, IN EACH CASE, A SHARP OBJECT CAME INTO CONTACT WITH THE SHEATH TUBE, CAUSING A SCRATCH, RESULTING IN A PINHOLE. THEREFORE, IT WAS JUDGED THAT IT WAS NOT A DEFECT CAUSED BY THE PRODUCT. WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT IN THE PCI PROCEDURE, THE INVOLVED RADIFOCUS INTRODUCER LL H WAS INSERTED FROM THE LEFT FEMORAL. AFTER CONTRALATERAL INJECTION WAS PERFORMED AND THE LESION WAS CONFIRMED, A COMPETITOR'S ANGIOGRAPHIC CATHETER WAS REMOVED. THEN, 10 TO 20 MINUTES AFTER THE SHIFTING FROM THE RIGHT FEMORAL TO PCI, BLEEDING WAS OBSERVED FROM THE LEFT PUNCTURE SITE. WHEN THE PRODUCT WAS REMOVED, IT WAS FOUND THAT A PINHOLE WAS FORMED ON THE SHEATH TUBE. THE PATIENT HAD MINOR HARM; DID NOT HAVE SERIOUS INJURY. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610655 RADIFOCUS INTRODUCER INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA 210512

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown