BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDEWIRE GT

    MDR report key: 7285172 · Received February 21, 2018

    Report

    Report Number
    9681834-2018-00014
    Event Type
    Injury
    Date Received
    February 21, 2018
    Date of Event
    January 24, 2018
    Report Date
    February 21, 2018
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G.5: 510(K): K955801, K170417 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 - 77 IS BASED UPON EVALUATION OF USER FACILITY INFORMATION & THE RETURNED SAMPLE; 71 IS BASED UPON EVALUATION OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION UPON RECEIPT FOUND THAT THE ACTUAL SAMPLE HAD BEEN FRACTURED AT THE DISTAL EXTREMITY. THE ACTUAL SAMPLE WAS MEASURED AND FOUND TO BE APPROXIMATELY 1798MM IN TOTAL LENGTH. SPECIFIED TOTAL LENGTH OF THIS PRODUCT CODE IS APPROXIMATELY 1800MM. THE ACTUAL SAMPLE WAS FOUND TO BE MISSING A SEGMENT APPROXIMATELY 2MM IN LENGTH. MAGNIFYING AND ELECTRON MICROSCOPIC INSPECTIONS OF THE FRACTURE END OBTAINED THE FINDINGS BELOW. THE URETHANE OUTER LAYER WAS FOUND TO BE PINCHED AND RIPPED OFF. THE CORE WIRE AND COIL WERE EXPOSED AT THE FRACTURED END. THE OUTSIDE DIAMETER OF THE ACTUAL SAMPLE WAS MEASURED ON THE UNDAMAGED SEGMENT AND FOUND TO MEET MANUFACTURER SPECIFICATIONS. THE URETHANE OUTER LAYER ON THE DISTAL SEGMENT WAS DISSOLVED AND REMOVED. THE FRACTURED ENDS OF THE EXPOSED CORE WIRE AND COIL WERE INSPECTED UNDER ELECTRON MICROSCOPE. BOTH THE CORE WIRE AND THE COIL WERE FOUND TO HAVE BEEN DIMINISHED TOWARD THE FRACTURED ENDS. A PRODUCT SAMPLE WAS SUBJECTED TO A ONE-WAY PULLING FORCE UNTIL IT BECAME FRACTURED. SUBSEQUENT ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURE REVEALED THE OUTSIDE DIAMETER OF THE WIRE HAD BEEN DIMINISHED TOWARD THE FRACTURE END. THE STATE OF THE DAMAGE SIMILAR TO THAT ON THE ACTUAL SAMPLE WAS DUPLICATED. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD FROM THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION WAS CONDUCTED WITH RELEVANT FINDINGS. A SEARCH OF THE COMPLAINT FILE DID NOT FIND ANY OTHER REPORT WITH THE INVOLVED PRODUCT /LOT# COMBINATION. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. WHILE THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION, IT IS LIKELY WHEN THE SWITCH OF THE DEVICE USED IN COMBINATION WITH THE ACTUAL SAMPLE WAS CLOSED, THE DISTAL SEGMENT OF THE ACTUAL SAMPLE WAS PINCHED WITH IT. SUBSEQUENTLY, IN THIS STATE, THE DISTAL SEGMENT PF THE ACTUAL SAMPLE WAS SUBJECTED TO PULLING FORCE WHICH EXCEEDED THE STRENGTH OF THIS PRODUCT, RESULTING IN THE REPORTED FRACTURE. THE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTION-FOR-USE (IFU) WITH STATEMENTS SUCH AS THE FOLLOWING: IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GUIDE WIRE GT AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. CONTINUING TO MANIPULATE OR ROTATE THE GUIDE WIRE GT OR FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDE WIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE VESSEL. 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 GLIDEWIRE GT DEVICE. IT WAS REPORTED THAT THE DOCTOR WITHDREW THE GT-WIRE AND THEN CLOSED THE FLOW CONTROL SWITCH, BUT ALL OF THE WIRE WAS NOT OUTSIDE SO THE TIP WAS DAMAGED FROM THE FCS. IT WAS REPORTED THAT THE TIP WENT INTO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT IMPACT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130712 GLIDEWIRE GT WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 161115

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other