BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDESHEATH

    MDR report key: 7946382 · Received October 9, 2018

    Report

    Report Number
    9681834-2018-00183
    Event Type
    Injury
    Date Received
    October 9, 2018
    Date of Event
    September 18, 2018
    Report Date
    October 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: DEVICE WAS IN PATIENT, HOWEVER, THE SEGMENT WAS 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 AND MAGNIFYING INSPECTIONS UPON RECEIPT REVEALED THE FOLLOWING. THE SHEATH TUBE HAD BEEN CRUSHED AT APPROXIMATELY 60MM AND 80MM FROM THE DISTAL END OF THE TUBE. THE SHEATH TUBE HAD BEEN FRACTURED AT APPROXIMATELY 93MM FROM THE DISTAL END OF THE TUBE (AT APPROXIMATELY 7MM FROM THE DISTAL END OF THE HUB). ACCORDING TO THE SPECIFICATIONS OF THIS PRODUCT CODE, THE TOTAL LENGTH OF THE SHEATH TUBE SHOULD BE 100MM. FROM THIS, IT LIKELY THAT THERE IS NO PORTION WHICH HAS BEEN SEPARATED AND IS MISSING FROM THE MAIN BODY OF THE ACTUAL DEVICE. ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURE CROSS-SECTION OBTAINED THE FINDINGS BELOW. THE TUBE WALL HAD BEEN ELONGATED AT THE FRACTURE END, WITH THE GENERATION OF SOME SCRATCHES ON THE SEGMENT ADJACENT TO THE FRACTURE END. THE SURFACE OF THE FRACTURE CROSS-SECTION OF THE TUBE WAS IN THE SMOOTH STATE. THE SHEATH TUBE WAS CUT VERTICALLY AT AN UNDAMAGED SEGMENT ADJACENT TO THE FRACTURE FOR FURTHER INSPECTION. MAGNIFYING INSPECTION OF THE CUT CROSS-SECTION OF THE TUBE VERIFIED THAT THE WALL THICKNESS WAS UNIFORM WITH NO DEFORMED SHAPE OF THE LUMEN. THE OUTSIDE AND INSIDE DIAMETERS AND THE WALL THICKNESS WERE MEASURED AND CONFIRMED TO MEET MANUFACTURER SPECIFICATIONS. A REPRODUCTIVE TEST WAS CONDUCTED. THE SHEATH TUBE OF A TEST SAMPLE WAS NICKED WITH A SUTURE NEEDLE ON THE OUTER SURFACE PARTIALLY. SUBSEQUENTLY, WITH THE DISTAL SEGMENT OF THE SHEATH TUBE BEING FIXED WITH THE FINGERS OF ONE HAND, THE SHEATH TUBE WAS PULLED IN THE DIRECTION OF WITHDRAWAL WITH THE OTHER HAND. THE SHEATH TUBE BECAME FRACTURED. THE FRACTURE CROSS-SECTION OF THE SHEATH TUBE WAS FOUND TO BE IN THE SMOOTH STATE PARTIALLY WITH SOME PORTION OF THE FRACTURED EDGE OF THE TUBE HAVING BEEN STRETCHED. THE STATE OF DAMAGE SIMILAR TO THAT ON THE ACTUAL DEVICE WAS DUPLICATED. 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 CAME INTO CONTACT WITH A SHARP OBJECT, INCLUDING A SUTURE NEEDLE, ON THE OUTER SURFACE OF THE SHEATH TUBE AND GOT NICKED PARTIALLY, BY WHICH ITS TENSILE STRENGTH WAS DETERIORATED. SUBSEQUENTLY, FURTHER PULLING FORCE APPLIED TO THE ACTUAL DEVICE DURING WITHDRAWAL FRACTURED THE SHEATH TUBE COMPLETELY. AS A CAUSE OF THE GENERATION OF THE CRUSHES ON THE SHEATH TUBE, IT IS LIKELY THAT THE SHEATH TUBE WAS EXPOSED TO COMPRESSIVE FORCE. HOWEVER, THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED. THE 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." 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.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A FRACTURE ON THE INVOLVED GLIDESHEATH DEVICE. A PUNCTURE WAS MADE ON THE FEMORAL VEIN FOR AN ARRHYTHMIA TREATMENT. AN 8-LETTER SUTURING WAS IMPLEMENTED NEAR THE PUNCTURED SEGMENT. THE ACTUAL SAMPLE WAS FRACTURED. THE CAUSE-AND-EFFECT RELATIONSHIP BETWEEN THE 8-LETTER SUTURING AND THE OCCURRENCE OF THE FRACTURE ON THE ACTUAL SAMPLE IS UNKNOWN. THE FRACTURED SEGMENT OF THE TUBE WAS REMOVED FROM THE PATIENT WITH A SNARE SUCCESSFULLY. FINAL PATIENT IMPACT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787842 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention