BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUNTHROUGH NS

    MDR report key: 7214889 · Received January 24, 2018

    Report

    Report Number
    9681834-2017-00281
    Event Type
    Malfunction
    Date Received
    January 24, 2018
    Date of Event
    December 24, 2017
    Report Date
    January 24, 2018
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510K - K080563 THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. FOR THIS REASON, EVALUATION CODE 20 HAS BEEN REFERENCED IN THE CONCLUSIONS SECTION OF H6. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE INVESTIGATION WAS BASED ON THE EVALUATION OF USER FACILITY INFORMATION AND EVALUATION OF A RETENTION SAMPLE FROM THE REPORTED PRODUCT CODE/LOT NUMBER COMBINATION. VISUAL INSPECTION REVEALED NO DEFECTS. MAGNIFYING INSPECTION OF THE PLATINUM COIL AND STAINLESS STEEL COIL SEGMENTS DID NOT FIND ANY ANOMALY, SUCH AS AN IRREGULARLY DEFORMED SEGMENT. THE PLATINUM COIL, STAINLESS STEEL COIL AND NITI CORE WIRE WERE CONFIRMED TO HAVE BEEN JOINTED TO ONE ANOTHER SECURELY WITH NO LOOSENESS. MAGNIFYING INSPECTION OF THE UNCOILED SHAFT SEGMENT DID NOT FIND ANY ANOMALY, SUCH AS SHEARED PTFE COATING, IN THE APPEARANCE. THE OUTSIDE DIAMETERS WERE MEASURED RESPECTIVELY ON THE PLATINUM COIL, STAINLESS STEEL COIL SEGMENT AND ON THE UNCOILED SEGMENT. ALL MEASUREMENTS CONFIRMED TO MEET MANUFACTURER SPECIFICATIONS. THE IFU STATES: DO NOT REPOSITION THE TORQUE DEVICE WHILE GRASPING THE RUNTHROUGH NS. IT MAY RESULT IN BREAKAGE OF THE RUNTHROUGH NS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION AND WITHOUT THE COMPLAINT SAMPLE, THE INVESTIGATION FINDINGS VERIFIED THAT THE CURRENT PRODUCT SAMPLE WAS THE NORMAL PRODUCT.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE BALLOONS BECAME STUCK AT JOINT OF RUNTHROUGH NS MULTIPLE TIMES. IT WAS REPORTED THAT JOINT OF RUNTHROUGH NS BECOME LOOSE. THE POLYMER COATING (SLEEVE) ON WIRE BECOME LOOSE AND STARTED TO MOVE ON WIRE. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61113 RUNTHROUGH NS GUIDEWIRE CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 170830

    Patients

    Seq Age Sex Outcome Treatment
    1 APOLLO (BALLOON)| HIRYU (BALLOON)| SAPPHIRE(BALLOON)