BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDECATH

    MDR report key: 10780391 · Received November 3, 2020

    Report

    Report Number
    9681834-2020-00219
    Event Type
    Injury
    Date Received
    November 3, 2020
    Date of Event
    September 4, 2020
    Report Date
    November 3, 2020
    Product Code
    DQO
    PMA / PMN Number
    K090040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K) - K915414. THE ACTUAL SAMPLE AND THE CONCURRENTLY USED RADIFOCUS GUIDEWIRE M WERE DISCARDED BY THE USER. FOUR SAMPLES OF THE INVOLVED PRODUCT CODE/LOT# WERE RETURNED FROM THE FACILITY'S STOCK. INSPECTION OF THE FOUR RETURNED SAMPLES OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION. THE RETUNED SAMPLES ARE CALLED SAMPLE A, SAMPLE B, SAMPLE C, AND SAMPLE D IN THIS REPORT AND INSPECTED AS FOLLOWS. VISUAL INSPECTION AND MAGNIFYING INSPECTION OF SAMPLE A THROUGH D REVEALED THAT THE HYDROPHILIC COATING SECTIONS HAD NO KINKS, NO CRUSHES, OR NO OTHER VISIBLE ANOMALIES. THE OTHER SECTIONS OTHER THAN THE HYDROPHILIC COATING SECTIONS ALSO HAD NO KINKS, NO CRUSHES, OR NO OTHER VISIBLE ANOMALIES. LUBRICITY OF THE AREA 0 MM - 400 MM FROM THE DISTAL END WAS CONFIRMED BY TACTILE SENSORY TEST. NO FRICTIONAL RESISTANCE WAS PERCEIVED FROM SAMPLE A THROUGH D, WHICH INDICATED THAT THE HYDROPHILIC COATING HAD BEEN APPLIED PROPERLY TO ALL OF THEM. X-RAY FLUOROSCOPIC INSPECTION OF SAMPLE A THROUGH D REVEALED NO ANOMALY SUCH AS AN OBSTRUCTION IN THEM. THE INSIDE AND OUTSIDE DIAMETERS WERE MEASURED. IT WAS CONFIRMED THAT SAMPLE A THROUGH D MET THE SPECIFICATIONS. REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION CONFIRMED THAT THERE WERE NOT ANY PROBLEMS IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION FROM OTHER FACILITIES. THE INVESTIGATION RESULT VERIFIED THAT SAMPLE A THROUGH D HAD NO ANOMALY IN THE DIMENSION AND IN THE LUBRICITY PERFORMANCE. WITH NO ACTUAL SAMPLE RETURNED FOR EVALUATION, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. IFU STATES: CONSIDER THE USE OF SYSTEMIC HEPARINIZATION TO PREVENT OR REDUCE THE POSSIBILITY OF THROMBUS FORMATION ON THE SURFACE OF THE CATHETER. THIS REPORT IS FOR THE RF-XL95110L DEVICE REPORTED, FOR THE RADIFOCUS GUIDEWIRE M DEVICE REPORTED THAT WAS USED IN COMBINATION WITH THE ACTUAL DEVICE SEE MDR 9681834-2020-00221. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS GLIDECATH WAS USED DURING THE CEREBRAL ANGIOGRAPHY (CAG) CASE. THROMBUS OCCURRED. THE PROCEDURE OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 07OCT2020. HARM TO THE PATIENT COULD NOT BE CONFIRMED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247337 RADIFOCUS GLIDECATH CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO NA 191101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R