BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS INTRODUCER

    MDR report key: 12924636 · Received December 3, 2021

    Report

    Report Number
    9681834-2021-00221
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    November 8, 2021
    Report Date
    December 3, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K033681
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K)- K062858, K082644. (B)(4). THE ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION. ELEVEN SAMPLES OF THE INVOLVED PRODUCT CODE/LOT # WERE RECEIVED. REVIEW OF THE IMAGE PROVIDED BY THE USER FOUND THAT THE DISTAL PORTION OF ABOUT 15 MM IN LENGTH WAS MISSING FROM THE PLASTIC CANNULA. THE PLASTIC CANNULA IS MANUFACTURED BY JOINING THE TUBE AND HUB, HOWEVER, THE BROKEN PART IN THIS CASE WAS NOT THAT JOINT PART. INSPECTION OF THE RETURNED 11 PIECES OF THE INVOLVED PRODUCT CODE/LOT: THE INDIVIDUAL PACKAGES WERE OPENED, AND THE PLASTIC CANNULAS WERE INSPECTED UNDER A MAGNIFIER. NO SCRATCH OR OTHER EXTERNAL ANOMALY WAS OBSERVED. 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 REINSERT THE INNER METALLIC NEEDLE INTO THE PLASTIC CANNULA. DISPOSE OF THE REMOVED INNER METALLIC NEEDLE SAFELY BEING CAREFUL TO AVOID INFECTIONS. NO ANOMALY WAS FOUND IN THE MANUFACTURING HISTORY RECORD. THE CONDITION OF THE ACTUAL SAMPLE COULD NOT BE CONFIRMED SINCE IT WAS NOT RETURNED TO THE FACTORY. THE RETURNED SAMPLES OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WERE CONFIRMED TO HAVE NO ANOMALY. THE PLASTIC CANNULA IS MANUFACTURED BY JOINING THE TUBE AND HUB, AND THE JOINT IS LOCATED AT 32MM FROM THE TIP. THEREFORE, IF THERE IS A DEFECT IN THE MANUFACTURING PROCESS, THE JOINT IS ANTICIPATED TO BREAK. SINCE THE BREAKAGE OF THE PLASTIC CANNULA IN THIS CASE WAS AT A DIFFERENT LOCATION THAN THE JOINT, IT WAS MOST UNLIKELY THAT THIS WAS A PRODUCT DEFECT. HOWEVER, 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 THE RADIFOCUS INTRODUCER LL H WAS USED DURING THE PROCEDURE. IN AN ATTEMPT TO PERFORM TRA WITH THIS PRODUCT, THE USER PUNCTURED WITH THE PUNCTURE NEEDLE IN QUESTION, INSERTED A MINI-GUIDEWIRE OF THE KIT, AND AFTER INSERTING THE SHEATH, THE USER NOTICED THAT THE TIP OF THE PLASTIC CANNULA THEY HAD REMOVED WAS TORN BY ABOUT 3 MM. SINCE THE TORN TIP WAS STILL INSIDE THE BODY, THEY TRIED TO REMOVE IT. ANOTHER RADIFOCUS GW WAS INSERTED FROM THE SIDE OF THE MINI-GUIDEWIRE, AND A 5-MM EVT BALLOON WAS DELIVERED THROUGH THE RADIFOCUS GW. THEY THOUGHT THAT THE TORN PORTION COULD BE PULLED IN THE PROXIMAL DIRECTION AND RETRIEVED BY DRAWING IT WITH THE BALLOON KEPT DILATED AT LOW PRESSURE LIKE FOGARTY BALLOON. HOWEVER, THE TORN PORTION COULD NOT BE REMOVED. SINCE ANGIOGRAM SHOWED NO OBSTRUCTION OF BLOOD FLOW DUE TO CLOGGING OF THE TORN PORTION, THEY DECIDED NOT TO MAKE ANY INCISION AND DECIDED TO FOLLOW-UP THE PATIENT. THE TORN PORTION WAS LEFT IN THE PATIENT. THE PATIENT WAS HARMED, NON-SERIOUS. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822096 RADIFOCUS INTRODUCER INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA 210406

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention EVT BALLOON| RADIFOCUS GW