BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDESHEATH

    MDR report key: 12458987 · Received September 13, 2021

    Report

    Report Number
    9681834-2021-00155
    Event Type
    Injury
    Date Received
    September 13, 2021
    Date of Event
    August 20, 2021
    Report Date
    September 13, 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

    Narratives

    Additional Manufacturer Narrative · 1

    UDI - NOT REQUIRED FOR THIS PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K)- K062858, K082644. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE ACTUAL SHEATH SAMPLE FOUND THAT THE SHEATH TUBE HAD BEEN FRACTURED. THE LENGTH OF THE SHEATH TUBE WAS MEASURED AND CONFIRMED THAT THE DISTAL PORTION WAS 80 MM, AND THE PROXIMAL PORTION WAS 20 MM. AS THE NORMAL SHEATH TUBE IS 100 MM IN LENGTH, IT WAS CONCEIVABLE THAT THERE WAS NO PORTION MISSING FROM THE SHEATH TUBE. MAGNIFYING INSPECTION OF THE ACTUAL SAMPLE FOUND A TRACE OF FORCEPS NEAR THE FRACTURE END OF THE DISTAL PORTION. BASED ON THE DESCRIPTION OF THE EVENT, IT WAS LIKELY TO HAVE BEEN CAUSED WHEN THE DISTAL PORTION WAS RETRIEVED WITH FORCEPS FROM THE PATIENT'S BODY. BOTH FRACTURE ENDS WERE FOUND NOT UNIFORM AND PARTIALLY ELONGATED. THE FRACTURE END OF THE PROXIMAL PORTION HAD BEEN TWISTED. ELECTRON MICROSCOPIC INSPECTION OF THE DISTAL PORTION FOUND THAT THE FRACTURE SURFACE WAS SMOOTH AND A SCRATCH LEADING TO THE FRACTURE SURFACE WAS OBSERVED. THE EXTREME END OF THE ELONGATED PART SEEMED TO HAVE BEEN STRETCHED AND TORN OFF. ELECTRON MICROSCOPIC INSPECTION OF THE PROXIMAL PORTION FOUND THAT THE FRACTURE SURFACE WAS SMOOTH AND MULTIPLE SCRATCHES LEADING TO THE FRACTURE SURFACE WERE OBSERVED. THE EXTREME END OF THE ELONGATED PART SUGGESTED THAT IT HAD BEEN STRETCHED AND TORN OFF. BASED ON THE ABOVE INSPECTION RESULT, AS THE FRACTURE SURFACE WAS SMOOTH AND MULTIPLE SCRATCHES LEADING TO THE FRACTURE SURFACE WERE OBSERVED, IT WAS LIKELY THAT THE SHEATH TUBE WAS EXPOSED TO A SHARP OBJECT. SIMULATION TEST: BASED ON THE CONDITION OF THE ACTUAL SAMPLE AND THE CIRCUMSTANCES OF THIS EVENT, IT WAS ASSUMED THAT SOME SHARP OBJECT MIGHT HAVE COME INTO CONTACT WITH THE ACTUAL SAMPLE, CAUSING IT TO BE SCRATCHED, AND AFTERWARD, WHEN THE ACTUAL SAMPLE IN THAT DAMAGED STATE MIGHT HAVE BEEN SUBJECTED TO ROTATIONAL AND TENSILE LOADS, WHICH RESULTED IN THE FRACTURE. BASED ON THIS ASSUMPTION, A SIMULATION TEST WAS PERFORMED USING A NORMAL PRODUCT. AS A RESULT, THE FRACTURE ENDS WERE NOT UNIFORM AND PARTIALLY TWISTED/ELONGATED. THE EXTREME END OF THE ELONGATED PART HAD BEEN STRETCHED AND TORN OFF. THESE CHARACTERISTICS WERE IDENTICAL TO THOSE OBSERVED ON THE ACTUAL SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. IFU STATES: "WHEN PUNCTURING, SUTURING, OR INCISING THE TISSUE NEAR THE SHEATH, BE CAREFUL NOT TO DAMAGE THE SHEATH. DO NOT PUT A CLAMP ON THE SHEATH NOR BIND IT WITH A THREAD." BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. IT WAS LIKELY THAT SOME SHARP OBJECT MIGHT HAVE COME INTO CONTACT WITH THE ACTUAL SAMPLE DURING USE AND CAUSED A SCRATCH ON THE SHEATH TUBE. IN ADDITION, IT WAS THOUGHT THAT THE SHEATH TUBE MIGHT HAVE BEEN TORN STARTING FROM THE SCRATCH BY THE ROTATIONAL AND TENSILE LOADS DURING REMOVAL OF THE ACTUAL SAMPLE, WHICH RESULTED IN THE FRACTURE. 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 RADIFOCUS INTRODUCER WAS USED FOR ABLATION. AT THE END OF THE PROCEDURE, THE ACTUAL SHEATH (5FR. SHEATH), ONE 8FR SHEATH MADE BY ANOTHER COMPANY, AND ONE 12FR SHEATH HAD BEEN PLACED IN THE FEMORAL VEIN. IN A NORMAL CASE, THE LARGER SHEATH WOULD BE REMOVED FIRST, BUT IN THIS CASE, THE 5 FR SHEATH WAS REMOVED FIRST. BECAUSE THE THICKER SHEATHES REMAINED IN THE BLOOD VESSEL, THE RESISTANCE TO REMOVAL THE 5 FR SHEATH WAS SIGNIFICANT, AND AS A RESULT OF ATTEMPTING TO REMOVE IT WHILE APPLYING ROTATION, IT FRACTURED. THE FRAGMENT OF 5FR SHEATH WAS REMOVED BY FORCEPS THROUGH A SMALL INCISION IN THE SKIN. THE SHEATH WAS FRACTURED INSIDE THE PATIENT'S BODY, AND A SURGICAL INTERVENTION WAS PERFORMED TO RETRIEVE IT. THERE WAS HARM TO THE PATIENT'S HEALTH BUT NON-SERIOUS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356003 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA 200918

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ABBOTT 8FR SHEATH FAST-CATH SR0 TYPE| NIHON KOHDEN 12 FR SHEATH CATHETER SHEATH SET TRIO