BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDESHEATH

    MDR report key: 8495726 · Received April 9, 2019

    Report

    Report Number
    9681834-2019-00051
    Event Type
    Injury
    Date Received
    April 9, 2019
    Date of Event
    March 19, 2019
    Report Date
    April 9, 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

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510(K): K062858, K082644 H3: 3191- FRACTURED DEVICE WAS REMOVED FROM PATIENT THE ACTUAL SAMPLE WAS RECEIVED 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 SOME SMOOTH SECTIONS AND OTHER ELONGATED SECTIONS. ON THE SECTION ADJACENT TO THE DISTAL FRACTURE END, A TRACE WHICH IMPLIED THAT THE SHEATH TUBE HAD COME INTO CONTACT WITH A SHARP OBJECT WAS NOTED. REPRODUCTIVE TESTING WAS PERFORMED AND THE SHEATH TUBE OF A TEST SAMPLE WAS NICKED WITH A SCALPEL ON THE SURFACE PARTIALLY. SUBSEQUENTLY THE DISTAL SEGMENT OF THE SHEATH TUBE WAS PINCHED WITH THE FINGERS AND SUBJECTED TO A PULLING FORCE. A FRACTURE HAS DEVELOPED ON THE SHEATH TUBE, STARTING AT THE NICK. ON THE FRACTURE CROSS-SECTIONS, THE SHEATH TUBE WAS FOUND TO BE IN THE SMOOTH STATE PARTIALLY WITH SOME PORTION OF THE FRACTURED EDGE HAVING BEEN ELONGATED. THE STATE OF DAMAGE SIMILAR TO THAT ON THE ACTUAL DEVICE WAS DUPLICATED. THE SHEATH TUBE OF A TEST SAMPLE WAS PIERCED WITH AN ENTRY NEEDLE ON THE SURFACE PARTIALLY. SUBSEQUENTLY THE DISTAL SEGMENT OF THE SHEATH TUBE WAS PINCHED WITH THE FINGERS AND SUBJECTED TO A PULLING FORCE. A FRACTURE HAS DEVELOPED ON THE SHEATH TUBE, STARTING AT THE HOLE MADE WITH THE ENTRY NEEDLE. ON THE FRACTURE CROSS-SECTION, THE SHEATH TUBE WAS FOUND TO HAVE BEEN ENTIRELY ELONGATED. THE STATE OF DAMAGE WAS FOUND TO BE DIFFERENT FROM THAT ON THE ACTUAL DEVICE. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD OR COMPLAINT FILE. 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. THERE IS NO 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 GOT NICKED PARTIALLY. 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 ACTUAL RADIFOCUS INTRODUCER SAMPLE WAS USED IN A VT TREATMENT. THREE SHEATHS, INCLUDING THE ACTUAL SAMPLE, WERE PLACED IN THE VENOUS SIDE. AT THE COMPLETION OF THE PROCEDURE; WHEN THE DOCTOR INSERTED A WIRE INTO THE ACTUAL SAMPLE AND TRIED TO WITHDRAW IT, THE SHEATH TUBE BECAME FRACTURED IN THE PATIENT'S BODY. THE DISTAL FRACTURED TUBE WAS TAKEN OUT OF THE BODY THROUGH THE ACCESS SITE. THE PROCEDURE OUTCOME AND PATIENT IMPACT WAS REPORTED TO BE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288808 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention RADIFOCUS GUIDE WIRE| RADIFOCUS GUIDE WIRE