BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDESHEATH

    MDR report key: 8585841 · Received May 7, 2019

    Report

    Report Number
    9681834-2019-00071
    Event Type
    Injury
    Date Received
    May 7, 2019
    Date of Event
    April 10, 2019
    Report Date
    May 7, 2019
    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 · 0

    UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 510(K): K062858, K082644. (B)(4). THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE SHEATH TUBE HAD BEEN FRACTURED AT APPROXIMATELY 90 MM FROM THE DISTAL END OF THE DEVICE (AT APPROXIMATELY 10 MM FROM THE DISTAL END OF THE HUB). ACCORDING TO THE SPECIFICATIONS OF THIS PRODUCT, THE TOTAL LENGTH OF THE SHEATH TUBE SHOULD BE 100MM. FROM THIS, IT CAN BE DETERMINED THAT THERE IS NO SEGMENT SEPARATED AND MISSING FROM THE ACTUAL DEVICE. MAGNIFYING AND ELECTRON MICROSCOPIC INSPECTIONS OF THE FRACTURE CROSS-SECTIONS REVEALED THE FRACTURED TUBE HAD BEEN STRETCHED. THIS IMPLIES THAT THE ACTUAL SAMPLE WAS SUBJECTED TO PULLING FORCE. THE SURFACE OF THE FRACTURE CROSS-SECTION OF THE FRACTURE ON THE HUB SIDE WAS IN THE SMOOTH STATE, IMPLYING THAT THE SHEATH TUBE HAD COME INTO CONTACT WITH A SHARP OBJECT. REPRODUCTIVE TESTING WAS PERFORMED. THE SHEATH TUBE OF A TEST SAMPLE WAS NICKED WITH A SCALPEL ON THE SURFACE. THE NICK CROSS-SECTION WAS FOUND TO BE IN THE SMOOTH STATE. THIS STATE WAS FOUND TO BE SIMILAR TO THAT ON THE ACTUAL SAMPLE. THE SHEATH TUBE OF A TEST SAMPLE WAS PIERCED WITH AN ENTRY NEEDLE ON THE SURFACE. THE PIECE CROSS-SECTION WAS FOUND TO BE IN A ROUNDISH SHAPE. THIS STATE WAS FOUND TO BE DIFFERENT FROM THAT ON THE ACTUAL SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE 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. BASED ON THE INVESTIGATION RESULTS, IT IS LIKELY THAT THE ACTUAL DEVICE CAME INTO CONTACT WITH A SHARP OBJECT, INCLUDING A SCALPEL, ON THE OUTER SURFACE OF THE SHEATH TUBE AND BECAME PARTIALLY NICKED. DUE TO THIS, THE TENSILE STRENGTH OF THE SHEATH TUBE WAS DETERIORATED. FURTHER PULLING FORCE APPLIED TO THE ACTUAL DEVICE SUBSEQUENTLY FRACTURED THE SHEATH TUBE COMPLETELY. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.HE ANCHOR HAS BEEN PROPERLY PLACED OR THE DEVICE WILL NOT FUNCTION.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS INTRODUCER WAS USED; DURING ABLATION, THREE SHEATHS, IN THE ORDER OF: 6FR., 8FR. AND 8.5FR. WERE INSERTED INTO THE DISTAL FEMORAL ARTERY, WITH A CUT GIVEN TO THE SKIN FOR INSERTION OF 8FR. AND 8.5FR. IN ORDER TO BE FIXED, THE SHEATHS WERE TIED WITH A THREAD. DURING WITHDRAWAL, THE 6FR. WAS WITHDRAWN FIRST, WHEN THE USER FELT SOME RESISTANCE, IMPLYING THE SHEATH WAS CAUGHT IN SOMETHING; HE PULLED THE SHEATH AND FOUND THAT THE DISTAL SECTION WAS MISSING. THE VESSEL WAS CUT OPEN AND THE FRACTURED FRAGMENT WAS REMOVED FROM THE BODY SURGICALLY. THE PROCEDURE OUTCOME AND PATIENT CONDITION WAS REPORTED TO BE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378914 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA 190122

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention