BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDESHEATH

    MDR report key: 8416822 · Received March 13, 2019

    Report

    Report Number
    9681834-2019-00036
    Event Type
    Injury
    Date Received
    March 13, 2019
    Date of Event
    February 19, 2019
    Report Date
    March 13, 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 TWO POTENTIAL LOT NUMBER WERE REPORTED; SECOND LOT NUMBER: D4: LOT NUMBER- 181024 D4: EXPIRATION DATE - 31MAR2021 H4: DEVICE MANUFACTURE DATE - 24OCT2018 THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE SHEATH TUBE HAD BEEN FRACTURED AT APPROXIMATELY 30 MM FROM THE DISTAL END OF THE HUB; AT APPROXIMATELY 70 MM FROM THE DISTAL END OF THE DEVICE. THE SPECIFICATIONS OF THIS PRODUCT, THE TOTAL LENGTH OF THE SHEATH TUBE SHOULD BE 100MM. FROM THIS, IT IS LIKELY THAT A SEGMENT APPROXIMATELY 70MM IN LENGTH IS STILL INSIDE THE PATIENT'S BODY. A CRUSHED SECTION WAS FOUND AT APPROXIMATELY 2MM FROM THE DISTAL END OF THE HUB. THE FRACTURE END WAS INSPECTED UNDER ELECTRON MICROSCOPE. THE TUBE WAS FOUND TO HAVE BEEN STRETCHED AROUND THE FRACTURE END WITH A CUTTING GENERATED ON THE SECTION ADJACENT TO THE FRACTURE END. THE TUBE ON THE FRACTURE CROSS SECTION WAS FOUND TO HAVE A SMOOTH SURFACE. 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 INSIDE DIAMETERS AND WALL THICKNESS WERE MEASURED AND CONFIRMED TO MEET THE MANUFACTURER SPECIFICATIONS. REPRODUCTIVE TESTING WAS PERFORMED; THE SHEATH TUBE OF A TEST SAMPLE WAS GIVEN A SMALL CUTTING WITH A SUTURING NEEDLE ON THE OUTER SURFACE PARTIALLY. SUBSEQUENTLY THE DISTAL SEGMENT OF THE SHEATH TUBE WAS PINCHED WITH THE FINGERS AND SUBJECTED TO A PULLING FORCE IN THE DIRECTION OF WITHDRAWAL. THE SHEATH TUBE BECAME FRACTURED. THE FRACTURE CROSS-SECTION OF THE TUBE WAS FOUND TO BE IN THE SMOOTH STATE WITH SOME PORTION OF THE FRACTURED EDGE OF THE TUBE HAVING BEEN ELONGATED. THE STATE OF DAMAGE SIMILAR TO THAT ON THE ACTUAL DEVICE WAS DUPLICATED. A REVIEW OF THE DEVICE HISTORY RECORD FOR BOTH PRODUCT CODE/LOT# COMBINATIONS WAS CONDUCTED WITH NO FINDINGS. THE 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 SUTURING NEEDLE, ON THE OUTER SURFACE OF THE SHEATH TUBE AND MAY HAVE BEEN NOTCHED WITH IT PARTIALLY, BY WHICH ITS TENSILE STRENGTH WAS DETERIORATED. SUBSEQUENTLY, FURTHER PULLING FORCE APPLIED TO THE ACTUAL DEVICE DURING WITHDRAWAL FRACTURED THE SHEATH TUBE COMPLETELY. AS A CAUSE OF THE GENERATION OF THE CRUSH ON THE SHEATH TUBE, IT IS LIKELY THAT THE ACTUAL DEVICE WAS SUBJECTED TO COMPRESSIVE FORCE. 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 RADIFOCUS INTRODUCER II H BECAME FRACTURED DURING WITHDRAWAL OF THE CATHETER; FOR ABRASION FROM THE ACTUAL SAMPLE. THE FRACTURED SEGMENT STILL REMAINS INSIDE THE PATIENT'S BODY. THE PROCEDURE OUTCOME AND PATIENT IMPACT WAS REPORTED TO BE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209123 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA 180718

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 5FR. CATHETER