BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDESHEATH

    MDR report key: 10780062 · Received November 3, 2020

    Report

    Report Number
    9681834-2020-00224
    Event Type
    Injury
    Date Received
    November 3, 2020
    Date of Event
    October 9, 2020
    Report Date
    November 3, 2020
    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 · 1

    EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER; UDI - NOT REQUIRED FOR PRODUCT CODE; IMPLANTED DATE: DEVICE WAS NOT IMPLANTED; EXPLANTED DATE: DEVICE WAS NOT EXPLANTED; PMA/510(K)- K062858, K082644; DEVICE MANUFACTURER DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE ACTUAL SAMPLE CONFIRMED THAT IT HAD BEEN FRACTURED AT APPROXIMATELY 90 MM FROM THE DISTAL END (APPROXIMATELY 10 MM FROM THE DISTAL END OF THE HUB). AS FOR THE INVOLVED PRODUCT CODE, THE SPECIFIED SHEATH TUBE LENGTH IS 100 MM; IT WAS CONCEIVABLE THAT THE ACTUAL SAMPLE HAD NO MISSING PART IN THE SHEATH TUBE. MAGNIFYING INSPECTION OF THE PROXIMAL PORTION REVEALED: A PART OF THE FRACTURE END HAD BEEN ELONGATED, A PART OF THE FRACTURE END NEAR THE SMOOTH FRACTURE SURFACE HAD BEEN PUSHED AND STRETCHED FROM THE INSIDE TOWARD THE OUTSIDE, AND A PART OF THE FRACTURE END NEAR THE SMOOTH FRACTURE SURFACE HAD BEEN PUSHED INWARD. MAGNIFYING INSPECTION OF THE DISTAL PORTION REVEALED: THE FRACTURE END HAD BEEN ELONGATED PARTIALLY, AND DEFORMATION SEEMED TO BE A FORCEPS MARK WAS OBSERVED NEAR THE FRACTURED SECTION. ELECTRON MICROSCOPIC INSPECTION OF THE PROXIMAL PORTION REVEALED: THE FRACTURE END HAD BEEN ELONGATED PARTIALLY, NO ABRASIONS WERE OBSERVED NEAR THE FRACTURED SECTION, AND THE FRACTURE SURFACE WAS PARTIALLY SMOOTH. ELECTRON MICROSCOPIC INSPECTION OF THE DISTAL PORTION REVEALED: THE FRACTURE END HAD BEEN ELONGATED PARTIALLY, DEFORMATION SEEMED TO BE A FORCEPS MARK WAS OBSERVED NEAR THE FRACTURED SECTION, NO ABRASIONS OR NO OTHER ANOMALY WAS OBSERVED IN THE REMAINDER PART. REPRODUCTIVE TESTING WAS PERFORMED, AND A TEST SAMPLE WAS TRAPPED AT THE DISTAL END AND PULLED. THE WHOLE OF THE SHEATH TUBE WAS ELONGATED AND FRACTURED FINALLY. THE FRACTURE STATE WAS CONFIRMED TO BE DIFFERENT FROM THAT OF THE ACTUAL SAMPLE. A TEST SAMPLE WAS GIVEN A PENETRATING FLAW WITH A SCALPEL AND THEN PULLED UNTIL BEING FRACTURED. AS A RESULT, A PART THAT HAD BEEN PUSHED AND STRETCHED OUTWARD AND A PART THAT HAD BEEN PUSHED INWARD WERE OBSERVED IN THE FRACTURED SECTION. SOME PART HAD BEEN ELONGATED. A PART OF THE FRACTURE SURFACE WAS FOUND SMOOTH. THE FRACTURE STATE WAS SIMILAR TO THAT OF THE ACTUAL SAMPLE. A TEST SAMPLE WAS GIVEN A PENETRATING FLAW WITH A SUTURE NEEDLE AND THEN PULLED UNTIL BEING FRACTURED. AS A RESULT, A PART THAT HAD BEEN PUSHED, AND STRETCHED OUTWARD AND A PART THAT HAD BEEN PUSHED INWARD WERE OBSERVED IN THE FRACTURED SECTION. SOME PART HAD BEEN ELONGATED. A PART OF THE FRACTURE SURFACE WAS FOUND SMOOTH. THE FRACTURE STATE WAS SIMILAR TO THAT OF THE ACTUAL SAMPLE. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORD. IFU STATES: DO NOT SCRATCH THE SHEATH WITH NEEDLE POINT, CUTTING TOOL, OR OTHER EDGED TOOLS. 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 SHEATH TUBE FRACTURE WAS CAUSED BY THE FOLLOWING MECHANISM: A SHARP OBJECT CAME INTO CONTACT WITH THE ACTUAL SAMPLE CAUSING A PENETRATING FLAW IN THE SHEATH TUBE; DUE TO THE FLAW, THE TENSILE STRENGTH OF THE SHEATH TUBE WAS DETERIORATED. WHEN THE ACTUAL SAMPLE IN THAT DAMAGED STATE WAS SUBJECTED TO PULLING FORCE, IT GOT FRACTURED. 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 RADIFOCUS INTRODUCER WAS USED DURING THE PROCEDURE. AFTER A ARRHYTHMIA ABLATION WAS COMPLETED, WHEN THE DOCTOR TRIED TO REMOVE RR-A60K10A (THE ACTUAL SAMPLE), AND ANOTHER COMPANY'S PRODUCT (AGILIS (12FR) / SWARTZ (8.5FR X 2)) THAT HAD BEEN INSERTED INTO THE RIGHT FEMORAL VEIN. THE ACTUAL SAMPLE WAS FOUND BROKEN NEAR THE HUB. THE BLOOD VESSEL WAS CUTOFF, AND THE DISTAL PORTION REMAINED IN THE BODY WAS SURGICALLY RECOVERED WHILE BEING CHECKED UNDER FLUOROSCOPY. THREE 8FR SHEATHS (REPLACED WITH 2 AGILIS / SWARTZ AFTERWARD), AND THE ACTUAL SAMPLE WERE USED IN THE RIGHT FEMORAL VEIN DURING THE CASE. THE DOCTOR SAID THAT THE SHEATHS WERE INSERTED AFTER THE PUNCTURE AND INSERTION OF FOUR GUIDEWIRES WERE COMPLETED, SO THERE IS NO POSSIBILITY THAT THE ACTUAL SAMPLE WAS DAMAGED BY THE SURFLO. THE DOCTOR SPECULATES, THE AGILIS (12FR) AND SWARTZ (8.5FR X 2 ) SHEATHS, WHICH WERE SUBSTITUTED FOR THE 8FR SHEATHS, WERE INSERTED NEAR THE ACTUAL SAMPLE THAT HAD BEEN IN PLACE; AND THE ACTUAL SAMPLE MIGHT HAVE GOT TRAPPED BY THEM AND FRACTURED. AS OF (B)(6) 2020, THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241622 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention