BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUNTHROUGH NS

    MDR report key: 21797258 · Received April 8, 2025

    Report

    Report Number
    9681834-2025-00051
    Event Type
    Injury
    Date Received
    April 8, 2025
    Date of Event
    March 7, 2025
    Report Date
    April 8, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063695
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: N/A AT THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. THE ACTUAL SAMPLE WAS NOT RETURNED. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST COMPLAINT FILE. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. HOWEVER, SINCE THE ACTUAL SAMPLE WAS NOT RETURNED AND INVESTIGATION OF IT COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOUR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE RUNTHROUGH NS AND/OR THE DILATATION CATHETER AND DETERMINE THE CAUSE BY HIGH RESOLUTION FLUOROSCOPY. FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDE WIRE'S TIP, DAMAGE TO THE DILATATION CATHETER, OR DAMAGE TO THE VESSEL." TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE INVOLVED PRODUCT WAS USED TO TREAT A DIFFUSE LESION WITH CALCIFICATION OF LAD#6-7 AND A SEVERE STENOSIS LESION AT THE D1 OSTIAL. THE PRODUCT WAS INSERTED INTO D1 UNDER THE SUPPORT WITH ZIZAI, THE LEFT ANTERIOR DESCENDING (LAD) WAS PREDILATED WITH A CUTTING BALLOON, AND A DES WAS PLACED IN THE DISTAL PART. D1 WAS THEN DILATED USING A 1.5MM BALLOON. SINCE THERE WAS CALCIFICATION AT D1 OSTIAL, JBT (JAILED BALLOON TECHNIQUE) WAS NOT PERFORMED, AND A DES WAS PLACED IN THE PROXIMAL #6. SUBSEQUENT ANGIOGRAPHY WAS PERFORMED AFTER REMOVAL OF THE WIRE SHOWED FINDINGS SUGGESTIVE OF SPASM AT LAD PERIPHERAL AND LEAKAGE OF CONTRAST AGENT AT D1 PERIPHERAL. REVIEWING THE ANGIOGRAPHIC FINDINGS, IT WAS POSSIBLE TO CONFIRM THAT THE PRODUCT THAT HAD BEEN PLACED AT D1 HAD PENETRATED THE PERIPHERY. THEREFORE, IN ORDER TO STOP THE BLEEDING, THE WIRE WAS INSERTED INTO THE LAD MAIN AGAIN AND IVUS WAS USED TO CONFIRM WHETHER THE WIRE HAD PASSED THROUGH THE STENT. USING A WLC (DOUBLE LUMEN CATHETER), RUN THROUGH ULTRAFLOPPY WAS USED IN D1 TO PASS THE STENT STRUT. THE STENT STRUT WAS DILATED WITH A 1.5MM BALLOON, AND AFTER REMOVING THE WLC, ZIZAI WAS INTRODUCED AND THE DISTAL END WAS ANGIOGRAPHICALLY CONFIRMED TO BE LEAKING CONTRAST AGENT AT THE PERIPHERY. FOR COIL EMBOLIZATION, THE MICROCATHETER WAS REPLACED FOR A FINECROSS, THE COIL WAS PLACED, AND IT WAS CONFIRMED THAT NO CONTRAST AGENT LEAKED OUT. FINALLY, THE PROCEDURE WAS COMPLETED AFTER ECHOCARDIOGRAPHY CONFIRMED THAT THERE WAS NO PERICARDIAL EFFUSION. THE PRODUCT PERFORATED A CORONARY ARTERY. THE PATIENT WAS HARMED AND MEDICAL INTERVENTION WAS PERFORMED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT RECOVERED FROM THE MINOR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768860 RUNTHROUGH NS WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA TW-AS418XHX 241028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O 2722| ALTAVIEW| C-STOPPER| GC-F6IL350N| KIZASHI2510| KURSADE TYPE R| KUSABI| MINAMO| NC-C783AM| NC-F863B| ONYX FRONTIER2226| SQ-AS6D16H| TW-AS418XHX| TW-GS418VDZ