BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 10732696 · Received October 26, 2020

    Report

    Report Number
    9681834-2020-00221
    Event Type
    Injury
    Date Received
    October 26, 2020
    Date of Event
    September 4, 2020
    Report Date
    October 26, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 07OCT2020. HARM TO THE PATIENT COULD NOT BE CONFIRMED. THROMBOSIS DEVELOPED IN THE PATIENT. NO ADDITIONAL CAG WAS PERFORMED. FOLLOW-UP OBSERVATION WAS PERFORMED. A RECOVERY TENDENCY WAS CONFIRMED. THE PATIENT IS WALKING WITH A CANE BECAUSE HE HAS VERTIGO DUE TO CEREBELLAR SYMPTOMS. ADDITIONAL INFORMATION WAS RECEIVED ON 08OCT2020. CEREBRAL INFARCTION APPEARED IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 13OCT2020. LOCATION OF THE DISEASE WAS THE CEREBELLUM. CAG WAS PRE-OPERATIVE. THE PLANNED PROCEDURE/TREATMENT WAS A COIL EMBOLIZATION OF THE CEREBRAL ANEURYSM. 0.035" RADIFOCUS WAS USED BECAUSE OF FEMORAL APPROACH (THEY USE 0.032" RADIFOCUS IF IT IS BRACHIAL APPROACH.). 33 ML OF IOMEPROL WAS USED. IN CASE OF ROUTINE CAG, 2000 UNIT OF HEPARIN WAS USED. NO OTHER DRUG WAS USED. THEY DID NOT NOTICE THE THROMBUS DURING CAG, BUT AFTER THE OPERATION (IN 5 TO 6 HOURS AFTER THE OPERATION, WHEN THE BED REST WAS RELEASED), THEY NOTICED THE PATIENT'S ABNORMALITY AND TOOK AN MRI TO CONFIRM THE CEREBRAL INFARCTION. NO ADDITIONAL CAG WAS PERFORMED, AND FOLLOW-UP OBSERVATION WAS PERFORMED. A RECOVERY TENDENCY WAS CONFIRMED. THE PATIENT WAS WALKING WITH A CANE; PATIENT HAS VERTIGO DUE TO CEREBELLAR SYMPTOMS. THE PATIENT WAS DISCHARGED, AND OUTPATIENT REHABILITATION WAS CURRENTLY BEING CARRIED OUT. COIL EMBOLIZATION FOR CEREBRAL ANEURYSM WAS PLANNED TO BE PERFORMED WITHIN THIS YEAR (IN THREE MONTHS FROM CAG), BUT THE TREATMENT DATE HAS BEEN POSTPONED TO THE BEGINNING OF THE YEAR.

    Additional Manufacturer Narrative · 1

    LOT NUMBER: REQUESTED, NOT PROVIDED. EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K)- K122590, K926214. DEVICE MANUFACTURER DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD. WITH NO RETURN OF THE ACTUAL DEVICE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. THIS REPORT IS FOR THE RADIFOCUS GUIDEWIRE M DEVICE REPORTED, FOR THE RF-XL95110L DEVICE REPORTED THAT WAS USED IN COMBINATION WITH THE ACTUAL DEVICE SEE MDR 9681834-2020-00219. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS GUIDEWIRE M WAS USED IN A CEREBRAL ANGIOGRAPHY CASE AND THROMBOSIS OCCURRED. THE ACTUAL SAMPLE WAS USED IN COMBINATION WITH AN ANGIOGRAPHIC CATHETER RF-XL95110L. MEDICAL/SURGICAL INTERVENTION PERFORMED TO OVERCOME THE SITUATION. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT'S FINAL HEALTH IMPACT WAS REPORTED TO BE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197064 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R HEPARIN 2000 UNIT| IOMEPROL 33 ML| MEDIKIT 5FR 25CM SHEATH| TERUMO 0.035RADIFOCUS 150CM| TERUMO ANGIOGRAPHIC CATHETER RF-XL95110L| MEDIKIT 5FR 25CM SHEATH| TERUMO ANGIOGRAPHIC CATHETER RF-XL95110L