BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS INTRODUCER

    MDR report key: 9726383 · Received February 19, 2020

    Report

    Report Number
    9681834-2020-00013
    Event Type
    Malfunction
    Date Received
    February 19, 2020
    Date of Event
    January 17, 2020
    Report Date
    February 19, 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

    UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 510(K): K062858, K082644. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND MAGNIFYING INSPECTION OF THE ACTUAL SHEATH SAMPLE FOUND IT HAD BEEN FRACTURED AT APPROXIMATELY 80MM FROM THE DISTAL END. ELECTRON MICROSCOPIC INSPECTION OF THE SHEATH REVEALED SOME GROOVES NEAR THE FRACTURE END, WHICH SEEMED TO HAVE BEEN CAUSED BY SOME SHARP OBJECT. THE FRACTURE END WAS FOUND SMOOTH AND STRETCHED PARTIALLY. BASED ON THIS, IT IS ASSUMABLE THAT THE SHEATH WAS DETERIORATED IN THE DURABILITY BY HAVING BEEN EXPOSED TO A SHARP-EDGED TOOL. WHEN THE SHEATH WAS EXPOSED TO PULLING FORCE, IT BECAME FRACTURED. MAGNIFYING INSPECTION OF THE SHEATH FOUND THAT THE DISTAL END OF THE SHEATH HAD BEEN WIDENED IN A TRUMPET-SHAPE. FROM THIS, IT WAS INFERRED THAT AN OBJECT LARGER IN THE OUTER DIAMETER THAN THE INNER DIAMETER OF THE DISTAL END OF THE SHEATH PASSED THROUGH THIS AREA. THE INNER DIAMETER AND THE WALL THICKNESS OF THE BODY OF THE SHEATH TUBE COULD NOT BE MEASURED BECAUSE IT HAD BEEN DEFORMED. THE SHEATH TUBE WAS CUT AND CONFIRMED THAT THE WALL THICKNESS WAS EVEN. REPRODUCTIVE TESTING WAS PERFORMED; AND A TEST SAMPLE WAS CUT WITH A SCALPEL AND THEN PULLED. AS A RESULT, THE SHEATH TUBE WAS FRACTURED. THE FRACTURE END WAS FOUND SMOOTH AND STRETCHED PARTIALLY; A TEST SAMPLE WITH NO CUT OR OTHER DAMAGE ON THE SHEATH TUBE WAS PULLED UNTIL IT WAS FRACTURED. THE SHEATH TUBE WAS STRETCHED MARKEDLY BEFORE BEING FRACTURED. STUDY OF THE DIFFICULTY IN INSERTING THE CONCURRENTLY USED DEVICE WITH X-RAY FLUOROSCOPIC INSPECTION OF THE SHEATH HOUSING REVEALED THAT THE SHEATH TUBE HAD BEEN INVERTED OVER ITSELF INSIDE THE HOUSING NEAR THE CAULKING PIN. AFTER THE HOUSING WAS DISASSEMBLED, THE CAULKING PIN WAS EVALUATED WITH MAGNIFIER AND CONFIRMED TO HAVE NO ANOMALY THAT COULD CAUSE THE SHEATH TUBE TO BECOME INVERTED. BASED ON OUR EXPERIENCES, IT IS KNOWN THAT THE SHEATH TUBE MAY BE INVERTED NEAR THE CAULKING PIN BY THE FOLLOWING MECHANISM; A CONCURRENTLY USED DEVICE WAS STUCK IN A SHEATH TUBE BECAUSE THE OUTER DIAMETER OF THE DEVICE IS LARGER THAN THE INNER DIAMETER OF THE BODY OF THE SHEATH TUBE; THE DEVICE IN SUCH A STICKING STATE IS PULLED IN THE WITHDRAWAL DIRECTION; THE DEVICE-STUCK PART OF THE SHEATH TUBE MOVES TOGETHER THE SHEATH TUBE OF THE AREA FREE FROM STUCK BECOME INVERTED IN THE SPACE BETWEEN THE CAULKING PIN AND THE DEVICE. STUDY OF THE POSSIBILITY OF MISSING PART IN THE SHEATH TUBE: THE DISTAL PIECE WAS CONFIRMED TO MEASURE APPROXIMATELY 80MM IN LENGTH, AND THE INVERTED PART INSIDE THE HOUSING WAS 10MM IN LENGTH (20MM WHEN RETURNED TO THE ORIGINAL STATE). BASED ON THIS, THE TOTAL LENGTH OF THE SHEATH TUBE WAS CONFIRMED TO BE 100MM, WHICH INDICATED THAT THERE WAS NO MISSING PART IN THE ACTUAL SHEATH SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION AND PRODUCT RELEASE DECISION CONTROL SHEET WAS CONDUCTED WITH NO FINDINGS. 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. A CAUSE OF THE FRACTURE WAS LIKELY DUE TO THE SHEATH TUBE LIKELY BEING EXPOSED TO A SHARP OBJECT ON THE OUTER SURFACE AND CUT PARTIALLY, RESULTING IN THE DETERIORATION OF THE DURABILITY OF THE SHEATH TUBE. SUBSEQUENTLY, WHEN THE SHEATH WAS WITHDRAWN, IT GOT FRACTURED. DIFFICULTIES IN PASSING THE CLOSURE DEVICE THROUGH THE ACTUAL SHEATH IS LIKELY TO HAVE ARISEN BECAUSE THE INNER DIAMETER OF THE SHEATH TUBE BECAME SMALLER THAN THE OUTER DIAMETER OF THE CLOSURE DEVICE AS IT HAD BEEN INVERTED OVER ITSELF INSIDE THE HOUSING. 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 DURING THE IABP CASE, THERE WAS AN ISSUE WITH THE INVOLVED RADIFOCUS INTRODUCER SHEATH. AFTER REMOVING THE BALLOON, THEY ATTEMPTED TO INSERT EXOSEAL THROUGH THE SHEATH TO CLOSE THE PUNCTURE SITE; HOWEVER, FAILED. THEY THEN TRIED TO INSERT A GUIDE WIRE AND FAILED. USE OF EXSOSEAL WAS SUSPENDED. HEMOSTASIS WAS DONE MANUALLY. THE PATIENT WAS NOT HARMED, AND THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191028 RADIFOCUS INTRODUCER INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA 190731

    Patients

    Seq Age Sex Outcome Treatment
    1