BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESHEATH

    MDR report key: 12252721 · Received July 30, 2021

    Report

    Report Number
    9681834-2021-00129
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    July 2, 2021
    Report Date
    July 30, 2021
    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

    LOT NUMBER - REQUESTED BUT UNKNOWN. UDI - N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. DEVICE MANUFACTURE DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. PMA/510(K)- K033681, K062858, K082644. VISUAL INSPECTION OF THE ACTUAL SAMPLE CONFIRMED THAT THE SHEATH TUBE HAD BEEN TORN AND DIVIDED IN TWO PIECES. THE DISTAL PIECE HAD BEEN BROKEN AT A POINT ABOUT 95 MM FROM THE DISTAL END. THE PROXIMAL PIECE HAD BEEN BROKEN AT A POINT ABOUT 35 MM FROM THE PROXIMAL END OF THE SHEATH TUBE. ABOUT 25 MM FROM 70 MM TO 95 MM FROM THE DISTAL END OF THE DISTAL PIECE HAD BEEN ELONGATED. AS FOR THE PROXIMAL PIECE, ABOUT 25 MM FROM 10 MM TO 35 MM FROM THE PROXIMAL END OF THE SHEATH TUBE HAD BEEN ELONGATED. MAGNIFYING INSPECTION OF THE BROKEN POINT OBTAINED THE FOLLOWING RESULTS. DISTAL PIECE OF THE SHEATH TUBE HAD BEEN TAPERED DUE TO THE ELONGATION. SCRATCHES HAD OCCURRED AT A REGULAR INTERVAL ABOUT 80 MM FROM THE DISTAL END AND THE SAME SCRATCHES WERE OBSERVED ON THE REVERSE SIDE. PROXIMAL PIECE OF THE SHEATH TUBE HAD BEEN TAPERED DUE TO THE ELONGATION. ON THE PROXIMAL SIDE OF THE BROKEN POINT, THERE WERE TRACES THAT HAD BEEN PUSHED IN FROM OUTSIDE AND TRACES THAT HAD BEEN PUSHED OUT FROM INSIDE. BOTH TRACES HAD OCCURRED FACING TO EACH OTHER ON THE CIRCUMFERENCE. FROM THE TAPERING OF THE SHEATH TUBE CAUSED BY THE ELONGATION, IT WAS INFERRED THAT A TENSILE LOAD WAS APPLIED TO THE SHEATH TUBE. FROM THE TRACE THAT HAD BEEN PUSHED IN FROM OUTSIDE AND THE OTHER THAT HAD BEEN PUSHED OUT FROM INSIDE, IT WAS INFERRED THAT SOMETHING HAD PIERCED THE SHEATH TUBE. BASED ON THE ABOVE RESULTS AND THE DESCRIPTION OF THE EVENT, IT WAS ASSUMED THAT THE ACTUAL SAMPLE WAS BROKEN DUE TO HAVING BEEN EXPOSED TO A TENSILE LOAD DURING REMOVED. BASED ON THIS ASSUMPTION, THE FOLLOWING SIMULATION TESTS WERE PERFORMED. SIMULATION TEST A: THE SHEATH TUBE WAS CLAMPED WITH FORCEPS, THE HOUSING WAS GRASPED, AND A TENSILE LOAD WAS APPLIED TO CAUSE A BREAKAGE. AS A RESULT, THE SHEATH TUBE BECAME ELONGATED FROM THE CLAMPED POINT TO THE SHEATH HOUSING OVER THE ENTIRE LENGTH. TAPERING OF SHEATH TUBE OR TRACES THAT THE SHEATH TUBE HAD BEEN PUSHED IN FROM THE OUTSIDE OR PUSHED OUT FROM INSIDE WAS NOT OBSERVED AT THE BROKEN POINT OF BOTH PIECES. SIMULATION TEST B: A SHEATH TUBE WAS PUNCTURED WITH A SUTURE NEEDLE, TIED WITH SUTURE THREAD, AND THEN EXPOSED TO TENSILE LOAD UNTIL IT GOT BROKEN. THE BROKEN POINT OF BOTH PIECES HAD BEEN ELONGATED AND TAPERED DUE TO THE ELONGATION. THE BROKEN POINT OF THE PROXIMAL PIECE HAD TRACES THAT THE SHEATH TUBE HAD BEEN PUSHED IN FROM OUTSIDE OR PUSHED OUT FROM INSIDE, WHICH INFERRED THAT THE SHEATH TUBE MIGHT HAVE BEEN PIERCED WITH A SUTURE NEEDLE. BASED ON THE ABOVE RESULT, THE STATE OF THE SIMULATION TEST SAMPLE B WAS MORE SIMILAR TO THAT OF THE ACTUAL SAMPLE. SINCE THE INVOLVED LOT NUMBER WAS UNKNOWN, REVIEW OF THE MANUFACTURING RECORD OR THE SHIPPING RECORD COULD NOT BE PERFORMED. SINCE THE INVOLVED LOT NUMBER WAS UNKNOWN, SEARCH OF THE COMPLAINT FILE COULD NOT BE PERFORMED. IFU STATES: DO NOT SCRATCH THE SHEATH WITH NEEDLE POINT, CUTTING TOOL, OR OTHER EDGED TOOLS. BASED ON THE INSPECTION RESULTS OF THE ACTUAL SAMPLE AND THE SIMULATION TESTS RESULT, IT WAS PRESUMED THAT THE SHEATH TUBE WAS PIERCED BY SOMETHING AND THEN BROKEN DUE TO A TENSILE LOAD DURING REMOVAL. FROM THE DESCRIPTION OF THE EVENT, THE OBJECT THAT PIERCED THE ACTUAL SAMPLE WAS CONCEIVABLE TO BE A SUTURE NEEDLE. AS FOR THE SCRATCHES OCCURRED AT A REGULAR INTERVAL ON BOTH SIDES AT THE SAME LOCATION, IT WAS PRESUMED THAT IT HAD BEEN CAUSED BY HAVING BEEN PINCHED WITH FORCEPS. SINCE THE DETAILED INFORMATION ABOUT THE PROCEDURE WAS UNKNOWN, THE DEFINITE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE GLIDESHEATH SLENDER WAS USED IN AN ABLATION CASE; THE BLEEDING WAS STOPPED WITH A Z-SUTURE, AND WHEN THE SHEATH WAS REMOVED, THERE WAS RESISTANCE, AND WHEN IT WAS PULLED OUT, THE SHEATH WAS BROKEN OFF. THE SHEATH WAS REMOVED, AND THEN BLEEDING WAS STOPPED BY A SUTURE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THE PATIENT WAS NOT HARMED. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED TO PREVENT INJURY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150189 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1