BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDESHEATH

    MDR report key: 8399717 · Received March 7, 2019

    Report

    Report Number
    9681834-2019-00018
    Event Type
    Injury
    Date Received
    March 7, 2019
    Date of Event
    January 23, 2019
    Report Date
    March 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
    AS
    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) NO. - K062858,K082644 H6: DEVICE CODE - 3191 (NO CODE AVAILABLE) - THE FRACTURED PIECE WAS IN THE PATIENT, HOWEVER, WAS SURGICALLY REMOVED. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. VISUAL AND MAGNIFYING INSPECTIONS UPON RECEIPT FOUND THAT THE ACTUAL SAMPLE HAD BEEN FRACTURED AT APPROXIMATELY 30MM FROM THE DISTAL END OF THE DEVICE, WITH THE PITCH OF THE SPRING HAVING BEEN STRETCHED AT THE FRACTURE ENDS. THE SAFE WIRE HAD BEEN FRACTURED, WITH THE FRACTURED DISTAL EXTREMITY REMAINING IN THE DISTAL END OF THE FRACTURED SPRING. THERE WAS NOT ANY ANOMALY ON THE ENTRY NEEDLE. THE TOTAL LENGTH OF THE SAFE WIRE WAS CONFIRMED TO BE APPROXIMATELY 800MM, WHICH IS THE EQUIVALENT LENGTH OF THAT OF THIS PRODUCT CODE. FROM THIS IT IS MOST LIKELY THAT THERE WAS NOT ANY SEGMENT MISSING FROM THE ACTUAL SAMPLE. THE FRACTURE CROSS-SECTIONS OF THE SAFE WIRE AND THE SPRING WERE ELECTRON MICROSCOPICALLY INSPECTED. THE SAFE WIRE HAD BEEN DIMINISHED TOWARD THE FRACTURE END. THE FRACTURE CROSS SECTIONS OF THE SPRING WERE IN THE FLAT STATE. THE OUTSIDE DIAMETER WAS MEASURED ON THE UNDAMAGED SECTION AND CONFIRMED TO MEET THE SPECIFICATIONS. REPRODUCTIVE TESTING WAS CONDUCTED. A CURRENT MINI SPRING GUIDE WIRE SAMPLE WAS INSERTED INTO A METAL NEEDLE AND WAS LET TO COME CLOSE CONTACT WITH THE BEVELED END OF THE METAL NEEDLE INTENTIONALLY BY GIVING THEM A SHARP ANGLE. IN THIS STATE, THE MINI GUIDE WIRE SAMPLE WAS WITHDRAWN FROM THE METAL NEEDLE. THE SPRING GOT FRACTURED. THE CONFIGURATION OF THE DAMAGE GENERATED ON THE MINI SPRING WIRE WAS CONFIRMED TO BE SIMILAR TO THAT OF THE ACTUAL SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION AND THE EXACT CAUSE CANNOT BE DEFINITIVELY DETERMINED. HOWEVER, BASED ON THE INVESTIGATION, IT IS LIKELY THAT THE ACTUAL SAMPLE WAS SUBJECTED TO EXCESSIVE PULLING FORCE BY BEING WITHDRAWN FROM THE INVOLVED METAL NEEDLE IN THE STATE OF HAVING CLOSE CONTACT WITH THE BEVELED END OF THE NEEDLE, RESULTING IN THE REPORTED FRACTURE. THE IFU STATES: DO NOT WITHDRAW THE GUIDE WIRE THROUGH THE CANNULA, AS SHEARING OF THE GUIDE WIRE MAY RESULT. IF RESISTANCE IS MET, DO NOT ADVANCE OR WITHDRAW THE MINI GUIDE WIRE UNTIL THE CAUSE OF RESISTANCE IS DETERMINED. 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 THAT THE VENOUS WIRE INSITU (IN FEMORAL VEIN) HOWEVER, THE PROXIMAL END WAS CAUGHT AT ACCESS SITE AND WOULD NOT BE ADVANCED. THIS REQUIRED REMOVAL OF THE WIRE AT WHICH STAGE, THE WIRE UNRAVELED AND BROKE LEAVING AN APPROX. 2CM LENGTH INSITU (SUBCUTANEOUS TISSUE). THIS WAS SUBSEQUENTLY SURGICALLY REMOVED AND THE CASE CANCELLED. THE FRACTURED PIECE WAS SUBSEQUENTLY SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191263 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA 180910

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TERUMO SHEATH - 1RSB70N10MR5| TERUMO SHEATH - 1RSB70N10MR5