BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS INTRODUCER

    MDR report key: 10194465 · Received June 25, 2020

    Report

    Report Number
    9681834-2020-00107
    Event Type
    Malfunction
    Date Received
    June 25, 2020
    Date of Event
    May 28, 2020
    Report Date
    June 25, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K033681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 510(K): K062858, K082644. DEVICE MANUFACTURE DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE SHEATH TUBE HAD BEEN FRACTURED AT APPROXIMATELY 100MM FROM THE DISTAL END AND SEPARATED FROM THE HUB. ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURE REVEALED: HUB SIDE: FINE SPILT HAD BEEN GENERATED ON TWO POINTS; NO ELONGATION WAS OBSERVED, DISTAL SHEATH TUBE SIDE: SOME SCRATCHES WERE OBSERVED NEAR THE FRACTURE SECTION; NO ELONGATION WAS OBSERVED. MAGNIFYING INSPECTION OF THE SHEATH TUBE FOUND THAT IT HAD BEEN COMPRESSED OVER THE ENTIRE LENGTH. REPRODUCTIVE TESTING WAS PERFORMED, AND A TEST SAMPLE WAS GIVEN SOME NICKS ON THE SHEATH TUBE CIRCUMFERENTIALLY, AND THEN EXPOSED TO PULLING FORCE. AS A RESULT, THE SHEATH TUBE WAS FRACTURED AT THE POINT WHERE NICKS WERE GIVEN. NO ELONGATION WAS NOTED. A TEST SAMPLE WITH NO FLAW ON THE SHEATH TUBE WAS EXPOSED TO PULLING FORCE. THE SHEATH TUBE BECAME FRACTURED AFTER ELONGATED. BASED ON THE TEST RESULTS, IT WAS LIKELY THAT THE ACTUAL SAMPLE HAD HAD SOME FLAW ON THE SHEATH TUBE WHEN IT WAS EXPOSED TO PULLING FORCE. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD OR THE SHIPPING INSPECTION RECORD. IFU STATES: DO NOT SCRATCH THE SHEATH WITH NEEDLE POINT, CUTTING TOOL, OR OTHER EDGED TOOLS. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE DESCRIPTION OF THE EVENT, IT IS LIKELY THAT THE ACTUAL SAMPLE HAD NO ANOMALY DURING USE. BASED ON THE INVESTIGATION RESULTS, IT IS LIKELY THAT THE ACTUAL SAMPLE, DURING BEING REMOVED FROM THE PATIENT, WAS EXPOSED TO A SHARP OBJECT WITH RESULTANT DAMAGE ON THE SHEATH TUBE, WHICH COULD LEAD TO DETERIORATION IN THE PULLING RESISTANCE. SUBSEQUENTLY, WHEN THE ACTUAL SAMPLE WAS EXPOSED TO FURTHER PULLING FORCE, THE SHEATH TUBE WAS FRACTURED. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE RADIFOCUS INTRODUCER WAS USED DURING THE PROCEDURE AND WAS INSERTED IN THE PATIENT IN THE ICU. BLEEDING WAS FOUND THE NEXT MORNING. WHILE COMPRESSION WAS GIVEN MANUALLY, THE SHEATH WAS WITHDRAWN, AND THEN REVEALED THAT IT HAD BEEN FRACTURED AT THE ROOT OF THE HUB. THERE WERE NO RESIDUES IN THE PATIENT BODY. COMPRESSION WAS GIVEN MANUALLY TO STOP THE BLEEDING. NO PARTICULAR ISSUE WAS INCURRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658468 RADIFOCUS INTRODUCER INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1