BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESHEATH

    MDR report key: 8649604 · Received May 29, 2019

    Report

    Report Number
    9681834-2019-00080
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Date of Event
    April 23, 2019
    Report Date
    May 29, 2019
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K033681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. THE 510(K): K062858, K082644. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE SHEATH TUBE WAS FRACTURED AT APPROXIMATELY 60MM FROM ITS DISTAL END (AT APPROXIMATELY 40 MM FROM THE DISTAL END OF THE HUB). ACCORDING TO THE SPECIFICATIONS OF THIS PRODUCT, THE TOTAL LENGTH OF THE SHEATH TUBE SHOULD BE 100MM. FROM THIS, IT CAN BE DETERMINED THAT THERE IS NO SECTION SEPARATED AND MISSING FROM THE ACTUAL SAMPLE. THE SHEATH TUBE HAD A TRACE AT APPROXIMATELY 60MM FROM ITS DISTAL END, WHICH IMPLIED THAT IT HAD BEEN PINCHED WITH FORCEPS. IT IS ASSUMABLE THAT THE TRACE WAS GENERATED ON THE SHEATH TUBE WHEN THE ACTUAL SAMPLE WAS RETRIEVED FROM THE PATIENT WITH FORCEPS. THE PROXIMAL FRACTURE CROSS-SECTION (ON THE HUB SIDE) WAS INSPECTED UNDER ELECTRON MICROSCOPE. THE DISTAL ONE WAS NOT INSPECTED DUE TO THE DAMAGE AT THE FRACTURE MADE BY FORCEPS. THE FRACTURED EDGE OF THE TUBE HAD BEEN STRETCHED; THIS IMPLIED THAT THE SHEATH TUBE WAS SUBJECTED TO PULLING FORCE DURING ITS WITHDRAWAL. THE FRACTURED EDGE HAD BEEN CURLED UP WITH A CUT GENERATED ON THE SECTION ADJACENT TO THE CURLED SECTION. THIS CURL IS LIKELY TO HAVE BEEN GENERATED BY A SHARP OBJECT. FROM THESE FINDINGS, IT IS LIKELY THAT THE SHEATH TUBE OF THE ACTUAL SAMPLE CAME INTO CONTACT WITH A SHARP OBJECT AND GOT CURLED UP AND CUT WITH IT PARTIALLY. DUE TO THIS DAMAGE, THE RESISTANCE OF THE SHEATH TUBE AGAINST PULLING FORCE WAS DETERIORATED, RESULTING IN THE FRACTURE WHEN THE SHEATH TUBE WAS SUBJECTED TO SUBSEQUENT PULLING FORCE DURING WITHDRAWAL. THE SHEATH TUBE WAS CUT VERTICALLY AT AN UNDAMAGED SEGMENT ADJACENT TO THE FRACTURE. MAGNIFYING INSPECTION OF THE CUT CROSS-SECTION VERIFIED THAT THE WALL THICKNESS WAS UNIFORM WITH NO DEFORMED SHAPE OF THE LUMEN. THE OUTSIDE AND INSIDE DIAMETERS WERE CONFIRMED TO MEET THE MANUFACTURER SPECIFICATIONS. REPRODUCTIVE TESTING WAS PERFORMED. A NICK WAS GIVEN TO THE OUTER SURFACE OF THE SHEATH TUBE OF A TEST SAMPLE WITH A SCALPEL. SUBSEQUENTLY, THE DISTAL SECTION WAS SUBJECTED TO PULLING FORCE. THE SHEATH TUBE BECAME FRACTURED AT THE NICK. THE FRACTURE CROSS-SECTION WAS FOUND TO BE IN THE STATE SIMILAR TO THAT ON THE FRACTURE OF THE ACTUAL SAMPLE, WITH THE EDGE OF THE FRACTURED TUBE HAVING BEEN STRETCHED AND CURLED UP. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. IFU STATES: WHEN PUNCTURING, SUTURING, OR INCISING THE TISSUE NEAR THE SHEATH, BE CAREFUL NOT TO DAMAGE THE SHEATH. 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 ACTUAL SAMPLE CAME INTO CONTACT WITH A SHARP OBJECT, INCLUDING A SCALPEL, ON THE SHEATH TUBE AND GOT NICKED AND CURLED UP PARTIALLY, DUE TO WHICH THE TENSILE STRENGTH OF THE SHEATH TUBE WAS DETERIORATED. SUBSEQUENTLY, WHEN PULLING FORCE WAS APPLIED TO THE ACTUAL SAMPLE FOR WITHDRAWAL, THE SHEATH TUBE BECAME FRACTURED COMPLETELY. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. 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 RADIFOCUS INTRODUCER BECAME FRACTURED WHEN A BALLOON WAS INSERTED INTO A LESION IN THE POPLITEAL ARTERY FOR DILATATION THROUGH THE ACTUAL SAMPLE. THE FRACTURED SECTION WAS RETRIEVED TOGETHER WITH THE MAIN BODY, WITH FORCEPS. WITH A NEW SHEATH, THE PROCEDURE WAS CONTINUED AND COMPLETED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445652 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA 180615

    Patients

    Seq Age Sex Outcome Treatment
    1