BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDESHEATH

    MDR report key: 7377998 · Received March 28, 2018

    Report

    Report Number
    9681834-2018-00039
    Event Type
    Injury
    Date Received
    March 28, 2018
    Date of Event
    March 9, 2018
    Report Date
    March 28, 2018
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G.5: 510(K): K062858 AND K082644 THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED 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. THE SHEATH TUBE WAS ALSO NOTED TO HAVE BEEN KINKED AT APPROX. 15MM, 30MM, 60MM AND 70MM RESPECTIVELY FROM ITS DISTAL END. MAGNIFYING INSPECTION OF THE FRACTURE CROSS-SECTIONS FOUND SOME EDGE PORTIONS BOTH ON THE HOUSING SIDE AND ON THE DISTAL SIDE HAD BEEN ELONGATED. THE CUT CROSS-SECTIONS WERE INSPECTED UNDER ELECTRON MICROSCOPE. ON BOTH SIDES, THE FRACTURE CROSS-SECTIONS, EXCLUDING THAT ON THE ELONGATED SEGMENT, WERE FOUND TO BE IN THE SMOOTH STATE. SOME ABRASIONS WERE NOTED ON THE SEGMENTS ADJACENT TO THE FRACTURES. FROM THIS, IT IS LIKELY THAT THE SHEATH TUBE CAME INTO CONTACT WITH A SHARP OBJECT AND GOT ABRADED WITH IT, BY WHICH THE TENSILE RESISTANCE OF THE TUBE GOT DETERIORATED. SUBSEQUENT APPLICATION OF THE PULLING FORCE DURING WITHDRAWAL RESULTED IN THE COMPLETE FRACTURE OF THE TUBE. THE SHEATH TUBE WAS CUT VERTICALLY AT AN UNDAMAGED SEGMENT ADJACENT TO THE FRACTURE FOR FURTHER INSPECTION. MAGNIFYING INSPECTION OF THE CUT CROSS-SECTION VERIFIED THAT THE WALL THICKNESS WAS UNIFORM WITH NO DEFORMED SHAPE OF THE LUMEN. THE OUTSIDE AND INSIDE DIAMETERS AND THE WALL THICKNESS WERE MEASURED AND CONFIRMED TO MEET THE SPECIFICATIONS. CUT CROSS-SECTION OF THE TUBE AFTER A VERTICALLY CUT. MAGNIFYING INSPECTION OF THE KINKED SEGMENTS FOUND THAT THEY HAD THE TRACE WHICH IMPLIED THAT THE SHEATH TUBE BEEN PINCHED WITH AN OBJECT. IT IS LIKELY THAT THE KINKS WERE GENERATED DURING THE RETRIEVAL OF THE FRACTURED SHEATH TUBE FROM THE PATIENT'S BODY. REPRODUCTIVE TESTING WAS PERFORMED AS FOLLOWS: THE SHEATH TUBE OF A TEST SAMPLE WAS CUT WITH AN ENTRY NEEDLE/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. THE SHEATH TUBE GOT FRACTURED. THE FRACTURE CROSS-SECTION WAS FOUND TO BE IN THE SMOOTH STATE PARTIALLY WITH SOME PORTION OF THE FRACTURED EDGE HAVING BEEN ELONGATED. SOME ABRASIONS WERE FOUND TO HAVE BEEN GENERATED ON THE SEGMENT ADJACENT TO THE FRACTURE. THE STATE OF DAMAGE SIMILAR TO THAT ON THE ACTUAL DEVICE WAS DUPLICATED. AFTER THE APPLICATION OF A CUT WITH AN ENTRY NEEDLE. A REVIEW OF THE DEVICE HISTORY RECORD AND THE PRODUCT RELEASE DECISION CONTROL SHEET FROM THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION WAS CONDUCTED WITH NO FINDINGS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. HOWEVER, BASED OFF THE INVESTIGATION, IT IS LIKELY THAT THE ACTUAL DEVICE CAME INTO CONTACT WITH A SHARP OBJECT, INCLUDING AN ENTRY NEEDLE OR A SCALPEL, ON THE SHEATH TUBE AND GOT CUT PARTIALLY, BY WHICH THE TENSILE STRENGTH WAS DETERIORATED. FURTHER PULLING FORCE APPLIED TO THE ACTUAL DEVICE SUBSEQUENTLY FRACTURED THE SHEATH TUBE COMPLETELY. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. THE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTION-FOR-USE (IFU) WITH STATEMENTS SUCH AS THE FOLLOWING: 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. 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.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED AFTER THE INVOLVED PROCEDURE, WHEN THE ACTUAL SAMPLE WAS WITHDRAWN FROM THE FEMORAL VEIN, THE SHEATH TUBE WAS FRACTURED AT APPROXIMATELY 5CM FROM THE DISTAL END OF THE TUBE AND REMAINED IN THE VESSEL. ATTEMPTS WERE MADE TO RETRIEVE THE FRACTURED PIECE VIA THE SUBCLAVIAN VEIN USING A GUIDING CATHETER AND A SNARE, HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL. EVENTUALLY THE FRACTURED PIECE WAS REMOVED FROM THE VESSEL SURGICALLY. AN ELECTRODE CATHETER WAS USE WITH THE REPORTED DEVICE. THE PATIENT RECOVERED FROM THE REPORTED SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220793 GLIDESHEATH INTRODUCER CATHETER DYB TERUMO CORPORATION, ASHITAKA NA 171011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other