BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDESHEATH

    MDR report key: 10763582 · Received October 30, 2020

    Report

    Report Number
    9681834-2020-00213
    Event Type
    Injury
    Date Received
    October 30, 2020
    Date of Event
    October 2, 2020
    Report Date
    October 30, 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

    UDI NOT REQUIRED FOR PRODUCT CODE; IMPLANTED DATE: DEVICE WAS NOT IMPLANTED; EXPLANTED DATE: DEVICE WAS NOT EXPLANTED; PMA/510(K)- K062858, K082644. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE CANNULA HAD BEEN FRACTURED AT APPROXIMATELY 30 MM FROM THE PROXIMAL END. AS THE SPECIFIED LENGTH OF THE CANNULA IS 70 MM, IT WAS LIKELY THAT THE ACTUAL PLASTIC CANNULA WAS DEFICIENT IN LENGTH BY 40 MM. MAGNIFYING INSPECTION OF THE PLASTIC CANNULA REVEALED THAT A PART OF THE FRACTURED SECTION HAD BEEN STRETCHED, AND A PART OF THE FRACTURE SURFACE WAS SMOOTH. ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURED SECTION REVEALED ABRASIONS WERE FOUND ALONG THE FRACTURE, AND A PART OF THE FRACTURE SURFACE WAS SMOOTH. REPRODUCTIVE TESTING WAS PERFORMED, AND A TEST SAMPLE IN THE STATE OF BEING TRAPPED AT APPROXIMATELY 40 MM FROM THE DISTAL END WAS SUBJECTED TO A TENSILE LOAD. AS A RESULT, THE PLASTIC CANNULA TUBE WAS STRETCHED OVER THE ENTIRE CIRCUMFERENCE AND FRACTURED FINALLY. THE FRACTURE STATE WAS FOUND DIFFERENT FROM THAT OF THE ACTUAL SAMPLE. AFTER SCRATCHING THE TEST SAMPLE WITH SCALPEL FROM THE OUTSIDE IN THE AREA ABOUT 40 MM FROM THE DISTAL END, THE AREA NEAR THE SCRATCHED WAS TRAPPED, AND A TENSILE LOAD WAS APPLIED UNTIL IT BECAME FRACTURED. THE FRACTURE SURFACE WAS SMOOTH AND PARTIALLY STRETCHED. THIS FRACTURE STATE WAS CONFIRMED TO BE SIMILAR TO THAT OBSERVED IN THE ACTUAL SAMPLE. TENSILE STRENGTH TEST WAS PERFORMED. TWO TEST SAMPLES WERE PREPARED AS THE SAME WAY IN THE REPRODUCTIVE TEST, AND THEN STRETCHED TO MEASURE THE TENSILE LOAD REQUIRED TO FRACTURE THEM. THE LENGTH OF THE STRETCHED PART WAS MEASURED ALSO. THE FOLLOWING RESULTS WERE OBTAINED. (NOTE: THE TENSILE STRENGTH OF THE PLASTIC CANNULA VARIES DEPENDING ON THE SHAPE OF SCRATCHES.) THE LENGTH OF THE STRETCHED PART OF THE SCRATCHED SAMPLE WAS SHORTER THAN THAT OF THE NON-SCRATCHED SAMPLE. THE SCRATCHED SAMPLE HAD LOWER TENSILE STRENGTH THAN THE NON-SCRATCHED SAMPLE. LENGTH OF THE STRETCHED PART: SCRATCHED: 2.0 MM; NON-SCRATCHED: 46.8MM. TENSILE LOAD WHEN FRACTURE OCCURRED: SCRATCHED: 5.3 N; NON-SCRATCHED: 6.6 N. A REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. IFU STATES: DO NOT PINCH THE PLASTIC CANNULA AND/OR THE SIDE TUBE WITH FORCEPS. IT WILL CAUSE SCRATCHES ON IT. ATTENTION SHOULD BE PAID NOT TO DAMAGE THE CANNULA WITH FORCEPS OR SHARP-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 PLASTIC CANNULA WAS FRACTURED BY THE FOLLOWING MECHANISM: SOME SHARP OBJECT MIGHT HAVE COME INTO CONTACT WITH THE PLASTIC CANNULA FROM THE OUTSIDE, CAUSING SOME SCRATCHES; WHEN THE PLASTIC CANNULA WAS BEING REMOVED, THE SCRATCHED PART WAS CAUGHT IN THE SKIN; WHEN THE SCRATCHED PART WAS EXPOSED TO A PULLING LOAD, IT BECAME 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 DEVICE WAS USED DURING THE PROCEDURE. IT WAS A CV PORT IMPLANTATION CASE, AND THE ACTUAL SAMPLE WAS USED TO APPROACH FROM SUBCLAVIAN. AFTER INSERTING A WIRE IN THE PLASTIC CANNULA, THE PLASTIC CANNULA BECAME STUCK AND COULD NOT BE REMOVED FOR AN UNKNOWN REASON. IT WAS NOT SURE WHETHER THE PLASTIC CANNULA HAD BEEN ROTATED OR NOT. A PART OF THE PLASTIC CANNULA WAS LEFT BEHIND THE PATIENT. THE SUBCLAVIAN WAS CUT DOWN TO FIND THE FRAGMENT; HOWEVER, FAILED. SINCE THE WIRE REMAINED, A 7FR SHEATH WAS INSERTED, AND THEN 8FR SHEATH WAS INSERTED IN FEMORAL TO INSERT A SNARE. AN ATTEMPT WAS MADE TO GRAB THE WIRE TO PERFORM PULL-THROUGH, HOWEVER, 7FR SHEATH CAME OFF. THE WHOLE SYSTEM WAS REMOVED, THEN THE INSIDE OF THE 7FR SHEATH WAS SEARCHED BUT NO FRAGMENT WAS FOUND IN IT. NO FRAGMENT WAS LEFT ON THE WIRE GRABBED WITH SNARE. A CT WAS DONE IMMEDIATELY HOWEVER, IT COULD NOT BE FOUND. FOLLOW-UP WAS CONTINUED IN HCU. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231568 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA 200217

    Patients

    Seq Age Sex Outcome Treatment
    1 Other