BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS INTRODUCER

    MDR report key: 10142143 · Received June 11, 2020

    Report

    Report Number
    9681834-2020-00103
    Event Type
    Malfunction
    Date Received
    June 11, 2020
    Date of Event
    March 6, 2020
    Report Date
    June 11, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K033681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AGE & DATE OF BIRTH - REQUESTED, NOT PROVIDED. PATIENT SEX - REQUESTED, NOT PROVIDED. WEIGHT - REQUESTED, NOT PROVIDED. ETHNICITY - REQUESTED, NOT PROVIDED. RACE - REQUESTED, NOT PROVIDED. UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. CONCOMITANT MEDICAL DEVICES: PERIPHERAL CUTTING BALLOON FROM BSC G5: 510(K): K062858, K082644. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT RELEASE DECISION CONTROL SHEET 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. BASED ON THE EVENT DESCRIPTION IT IS LIKELY THAT THE BALLOON MIGHT HAVE NOT BEEN DEFLATED COMPLETELY WHEN THE CUTTING BALLOON WAS PULLED OUT. THIS MIGHT HAVE CAUSED THE ATHEROTOME OF THE BALLOON TO COME INTO CONTACT WITH THE ACTUAL SHEATH SAMPLE WITH RESULTANT TORN ON THE SHEATH TUBE. HOWEVER, WITH NO RETURN OF THE ACTUAL DEVICE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. TERUMO MEDICAL PRODUCTS (TMP) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS INTRODUCER WAS USED DURING THE PROCEDURE. A PROCEDURE USING A 6.0X20 MM PERIPHERAL CUTTING BALLOON FROM BSC WAS PERFORMED ON THE LESION OF THE LEFT EXTERNAL ILIAC ARTERY WITH MODERATE TORTUOUSNESS AND MODERATE CALCIFICATION. THE LESION HAD A STENOSIS RATE OF 99%. THE CUTTING BALLOON WAS INSERTED INTO THE LESION AREA, THE BALLOON WAS EXPANDED AT 6 ATM FOR ABOUT 30 SECONDS, AND THEN REPOSITIONED SLIGHTLY, AND INFLATION WAS PERFORMED 3 TIMES AT 6-8 ATM FOR ABOUT 30 SECONDS. AFTER THAT, WHEN THE CUTTING BALLOON WAS PULLED INTO A 6FR SHEATH USED IN COMBINATION AND THEN PULLED OUT OF THE BODY, THE SHEATH WAS TORN FROM THE DISTAL END TO THE PROXIMAL PORTION. AFTER CHANGING IT TO A NEW 6FR SHEATH, THEY FOUND BLEEDING FROM THE PUNCTURE SITE. BLEEDING AT THE PUNCTURE SITE DID NOT STOP EVEN AFTER THE SHEATH WAS REPLACED WITH 7FR, SO THE PROCEDURE WAS CONTINUED WHILE HEMOSTASIS WAS MANAGED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD NO COMPLICATIONS AND THEIR CONDITION WAS STABLE; THERE WAS NO HARM. THE BLEEDING VOLUME WAS UNKNOWN. THERE WAS NO RESIDUE IN THE BODY REPORTED. IT IS UNKNOWN WHETHER THE 7FR SHEATH WAS FROM TERUMO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607066 RADIFOCUS INTRODUCER INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA 180919

    Patients

    Seq Age Sex Outcome Treatment
    1 PCB2CM OTW /6.0-20/4.2/90