BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESHEATH

    MDR report key: 8826122 · Received July 25, 2019

    Report

    Report Number
    9681834-2019-00134
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    July 1, 2019
    Report Date
    July 25, 2019
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K033681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 510(K): K062858, K082644. THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE SHEATH TUBE HAD BEEN TORN CIRCUMFERENTIALLY AT APPROXIMATELY 85MM FROM THE DISTAL END OF THE TUBE MORE THAN HALF WAY ROUND THE TUBE. THE TORN SECTIONS WERE CLOSELY INSPECTED UNDER X-RAY CT AND REVEALED A COUPLE OF INDENTATIONS HAD BEEN GENERATED ON THE DISTAL TORN SECTION. INSPECTION OF THE INDENTATIONS FROM THE LATERAL SIDE FOUND THAT ONE INDENTATION WAS A DEFORMITY GENERATED FROM THE OUTSIDE IN THE INSIDE DIRECTION AND THE OTHER INDENTATION WAS A DEFORMITY GENERATED FROM THE INSIDE IN THE OUTSIDE DIRECTION. FROM THESE FINDINGS, IT IS ASSUMABLE THAT THE SHEATH TUBE WAS PIERCED WITH AN OBJECT AND THEN SUBJECTED TO SOME PULLING FORCE. THE SHEATH TUBE WAS CUT VERTICALLY AT AN UNDAMAGED SEGMENT ADJACENT TO THE TORN SECTION 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 MANUFACTURER SPECIFICATIONS. REPRODUCTIVE TESTING WAS PERFORMED, AND THE SHEATH TUBE OF A TEST SAMPLE WAS PIERCED WITH A SUTURING NEEDLE. SUBSEQUENTLY, WITH THE SURGICAL SUTURE BEING FIXED, THE SHEATH TUBE WAS SUBJECTED TO PULLING FORCE. AS THE RESULT, THE SHEATH TUBE BECAME DAMAGED IN THE MANNER SIMILAR TO THE ACTUAL DEVICE WITH A COUPLE OF INDENTATIONS GENERATED RESPECTIVELY IN THE INWARD AND OUTWARD DIRECTIONS. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT/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. IT IS LIKELY THAT THE ACTUAL DEVICE WAS PIERCED FROM THE OUTSIDE WITH A SHARP OBJECT, INCLUDING A SUTURING NEEDLE AND GOT TORN PARTIALLY, BY WHICH ITS TENSILE STRENGTH WAS DETERIORATED. SUBSEQUENTLY, FURTHER PULLING FORCE APPLIED TO THE ACTUAL DEVICE DURING WITHDRAWAL DEVELOPED THE TEAR TO MORE THAN HALF WAY ROUND THE TUBE. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE INVOLVED GLIDESHEATH DEVICE WAS USED DURING THE PROCEDURE. THE APPROACH WAS MADE FROM THE FEMORAL VEIN. AFTER THE IMPLEMENTATION OF ABLATION, THE ACTUAL DEVICE WAS WITHDRAWN FROM THE VEIN BEFORE THE VEIN WAS COMPLETELY SUTURED. THE ACTUAL SAMPLE BECAME DEFORMED. THE DOCTOR. REMOVED THE ACTUAL SAMPLE FROM THE PATIENT CAREFULLY WITH WELL CONTROLLED HEMORRHAGE. THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE OUTCOME WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621641 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA 190315

    Patients

    Seq Age Sex Outcome Treatment
    1