BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDESHEATH

    MDR report key: 7766671 · Received August 9, 2018

    Report

    Report Number
    9681834-2018-00147
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    July 23, 2018
    Report Date
    August 9, 2018
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510(K): K062858, K082644 H6: PATIENT CODE: 3191 -NO CODE AVAILABLE: MEDICAL INTERVENTION REQUIRED - FRACTURED SEGMENT REMOVED FROM THE PATIENT. H6 - RESULTS - 3252 IS BASED ON EVALUATION OF USER FACILITY INFORMATION & THE RETURNED SAMPLE; 213 IS BASED UPON EVALUATION OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE. H6 - CONCLUSION - 4310 IS BASED UPON EVALUATION OF USER FACILITY INFORMATION & THE RETURNED SAMPLE; 67 IS BASED UPON EVALUATION OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION UPON RECEIPT REVEALED THAT THE ACTUAL DEVICE HAD BEEN FRACTURED AT APPROXIMATELY 108MM FROM THE DISTAL END OF THE DEVICE. A SNARE WAS FOUND TO BE ATTACHED TO THE ACTUAL DEVICE AT APPROXIMATELY 8MM FROM THE DISTAL END OF THE DEVICE. THE TOTAL LENGTH MEASURED AS FOLLOWS. DISTAL SEGMENT: APPROXIMATELY 108MM MAIN BODY: APPROXIMATELY 341MM IN TOTAL: APPROXIMATELY 449MM LENGTH SPECIFICATION OF THIS PRODUCT CODE: APPROXIMATELY 449MM. BASED ON THESE FINDINGS IT IS MOST LIKELY THAT THERE IS NO MISSING PORTION ON THE ACTUAL DEVICE. MAGNIFYING AND ELECTRON MICROSCOPIC INSPECTIONS OF THE FRACTURES OBTAINED THE FOLLOWING FINDINGS. DISTAL SEGMENT. THE CORE WIRE WAS EXPOSED. THE URETHANE OUTER LAYER HAD BEEN STRETCHED. THE CORE WIRE HAD BEEN FLEXED. THE SURFACE OF THE FRACTURE CROSS-SECTION WAS IN THE ROUGH STATE. MAIN BODY: THE URETHANE OUTER LAYER HAD BEEN STRETCHED. THE CORE WIRE HAD BEEN FLEXED. THE SURFACE OF THE FRACTURE CROSS-SECTION WAS IN THE ROUGH STATE. THE OUTSIDE DIAMETER WAS MEASURED ON THE UNDAMAGED SEGMENT AND VERIFIED TO MEET MANUFACTURER SPECIFICATIONS. A REPRODUCTIVE TEST WAS CONDUCTED. A MINI GUIDE WIRE SAMPLE WAS SUBJECTED TO EXCESSIVE LOCAL BENDING FORCE BY BENDING IT TO THE ANGLE OF 90 DEGREES AND THEN SUBJECTED TO PULLING FORCE. SUBSEQUENT INSPECTIONS OF THE FRACTURES OBTAINED THE FINDINGS BELOW. DISTAL SEGMENT THE CORE WIRE WAS EXPOSED. THE URETHANE OUTER LAYER HAD BEEN STRETCHED. THE CORE WIRE HAD BEEN FLEXED. THE SURFACE OF THE FRACTURE CROSS-SECTION WAS IN THE ROUGH STATE. MAIN BODY THE URETHANE OUTER LAYER HAD BEEN STRETCHED. THE CORE WIRE HAD BEEN FLEXED. THE SURFACE OF THE FRACTURE CROSS-SECTION WAS IN THE ROUGH STATE. THE FRACTURE THAT WAS DUPLICATED WAS SIMILAR TO THAT OF THE ACTUAL DEVICE. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT FILE. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE INVESTIGATION RESULT, IT IS LIKELY THAT THE ACTUAL DEVICE WAS EXPOSED TO EXCESSIVE LOCAL BENDING FORCE, WEAKENED BY METAL FATIGUE AND THE CORE WIRE BECAME FRACTURED. SUBSEQUENT PULLING FORCE ELONGATED AND RIPPED OFF THE URETHANE OUTER LAYER, RESULTING IN THE COMPLETE SEPARATION OF THE DISTAL SEGMENT. HOWEVER, REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. THE IFU STATES "ADVANCE OR WITHDRAW THE MINI GUIDE WIRE SLOWLY. 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.HE ANCHOR HAS BEEN PROPERLY PLACED OR THE DEVICE WILL NOT FUNCTION.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE ACTUAL SAMPLE WAS USED IN A EVT (ENDO VASCULAR TREATMENT) PROCEDURE. THE USER, AFTER HAVING TREATED THE RIGHT SFA, WANTED TO GO TO THE RIGHT ILIAC TO TREAT IT NEXT. THE USER TRIED TO TURN THE ACTUAL SHEATH SAMPLE THE OTHER WAY AROUND BY GIVING A BEND TO THE ACTUAL MINI GUIDE WIRE SAMPLE AT 10 CM FROM THE DISTAL END OF THE WIRE AND INSERTING IT RETROGRADELY, USING THE REVERSE WIRE TECHNIQUE. THE ACTUAL MINI GUIDE SAMPLE TURNED IN THE RETROGRADE DIRECTION BUT IT WOULD NOT BE ADVANCED FARTHER. WHEN THE USER PULLED THE DEVICE OUT, IT BECAME FRACTURED AND THE DISTAL SEGMENT REMAINED IN THE PATIENT. THE DISTAL FRACTURED SEGMENT WAS RETRIEVED FROM THE PATIENT WITH THE USE OF SNARE. HE USED A NEW SHEATH AND COMPLETED THE TREATMENT. IT WAS REPORTED THAT THERE WAS NO BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608258 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R