BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDESHEATH

    MDR report key: 7836495 · Received August 31, 2018

    Report

    Report Number
    9681834-2018-00138
    Event Type
    Injury
    Date Received
    August 31, 2018
    Date of Event
    August 15, 2018
    Report Date
    August 31, 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 SAMPLE HAD BEEN FRACTURED AT APPROXIMATELY 91MM FROM THE DISTAL END OF THE SHEATH TUBE (AT APPROXIMATELY 9MM FROM THE DISTAL END OF THE HUB). THE ACTUAL SAMPLE WAS MEASURED FOR THE TOTAL LENGTH AND IT WAS DETERMINED THERE IS NO MISSING PORTION ON THE ACTUAL SAMPLE. THE SHEATH TUBE HAD BEEN ELONGATED AT AND ADJACENT TO THE FRACTURE END. THE FRACTURE ENDS WERE INSPECTED UNDER ELECTRON MICROSCOPE. AT THE DISTAL FRACTURE END, THE FRACTURE CROSS-SECTION WAS IN THE SMOOTH STATE. AT THE PROXIMAL FRACTURE END (ON THE HUB SIDE), THE FRACTURE CROSS-SECTION WAS IN THE SMOOTH STATE, WITH SOME ABRASIONS FOUND ON THE SEGMENT ADJACENT TO THE FRACTURE END. THE SHEATH TUBE WAS CUT VERTICALLY ON THE SEGMENT ADJACENT TO THE FRACTURE AND THE CUT CROSS-SECTION WAS INSPECTED UNDER MAGNIFICATION. THERE WAS NO ECCENTRICITY IN THE SHAPE WITH THE WALL THICKNESS BEING UNIFORM. THE INSIDE DIAMETER 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 RESPECTIVELY WITH AN ENTRY NEEDLE, A SCALPEL AND A SUTURE NEEDLE ON THE OUTER SURFACE PARTIALLY. SUBSEQUENTLY, WITH THE DISTAL SEGMENT OF THE SHEATH TUBE BEING PINCHED AND FIXED WITH THE FINGERS OF ONE HAND, THE SHEATH TUBE WAS PULLED WITH THE OTHER HAND IN THE DIRECTION OF WITHDRAWAL. THE SHEATH TUBE BECAME FRACTURED. THE FRACTURE CROSS-SECTION WAS FOUND TO BE IN THE SMOOTH STATE PARTIALLY WITH SOME PORTION OF THE FRACTURED EDGE HAVING BEEN ELONGATED. THE STATE OF DAMAGE WAS OBSERVED TO BE SIMILAR TO THAT OF THE ACTUAL SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT/LOT NO. COMBINATION WAS CONDUCTED WITH NO FINDINGS. A SEARCH OF THE COMPLAINT FILE FOUND NO SIMILAR REPORT WITH THE INVOLVED PRODUCT/LOT NUMBER COMBINATION. 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 SAMPLE CAME INTO CONTACT WITH A SHARP OBJECT, INCLUDING AN ENTRY NEEDLE, A SCALPEL OR A SUTURE NEEDLE, ON THE OUTER SURFACE OF THE SHEATH TUBE AND BECAME NICKED PARTIALLY, DUE TO WHICH THE TENSILE STRENGTH OF THE SHEATH TUBE BECAME DETERIORATED. SUBSEQUENT PULLING FORCE APPLIED TO THE ACTUAL DEVICE DURING WITHDRAWAL FRACTURED THE SHEATH TUBE COMPLETELY. HOWEVER, THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED. THE IFU STATES "DO NOT SCRATCH THE SHEATH WITH NEEDLE POINT, CUTTING TOOL, OR OTHER EDGED TOOLS." 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 FOR AN ABLATION PROCEDURE. THE INVOLVED CATHETER FOR ABLATION BECAME STUCK IN THE ACTUAL SAMPLE. THE USER, IN AN ATTEMPT TO RELEASE THE CATHETER, PULLED THE CATHETER FORCEFULLY, WHEN THE ACTUAL SAMPLE BECAME FRACTURED. THE ACTUAL SAMPLE WAS CHANGED OUT TO A NEW ONE AND THE FRACTURED PIECE WAS WITHDRAWN FROM THE PATIENT WITH A SNARE. THE PROCEDURE WAS CONTINUED AND COMPLETED SUCCESSFULLY. FINAL PATIENT IMPACT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678810 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA 170622

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R UNKNOWN CATHETER FOR ABLATION| UNKNOWN CATHETER FOR ABLATION