BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 10732697 · Received October 26, 2020

    Report

    Report Number
    9681834-2020-00223
    Event Type
    Injury
    Date Received
    October 26, 2020
    Date of Event
    October 6, 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 08OCT2020. CEREBRAL INFARCTION APPEARED IN THE PATIENT.THROMBOSIS DEVELOPED IN THE PATIENT. NO ADDITIONAL CAG WAS PERFORMED. FOLLOW-UP OBSERVATION WAS PERFORMED. A RECOVERY TENDENCY WAS CONFIRMED. THE PATIENT HAD PARALYSIS IN THE AREA BEYOND HIS/HER LEFT WRIST, BUT WHEN HE/SHE WAS DISCHARGED, HIS/HER PARALYSIS WAS RECOVERED EXCEPT FOR HIS/HER THUMB. ADDITIONAL INFORMATION WAS RECEIVED ON 13OCT2020. PRE-OPERATIVE CAG FOR COIL EMBOLIZATION IN CEREBRAL ANEURYSM 2000 UNIT OF HEPARIN AND 45 ML OF IOMEPROL 300 WERE USED. AFTER THE BED REST LEVEL WAS ALLEVIATED, (AFTER 5 OR 6 HOURS) THEY NOTICED AN ABNORMALITY OF THE PATIENT. ON OCT 6, MRI WAS TAKEN, AND CEREBRAL INFARCT WAS CONFIRMED. THE PATIENT WAS DISCHARGED, ALTHOUGH PARALYSIS OF THUMB REMAINS. REHABILITATION WAS CARRIED OUT. ADDITIONAL INFORMATION WAS RECEIVED ON 15OCT2020. CAG WAS PERFORMED 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. IN CASE OF ROUTINE CAG, 2000 UNIT OF HEPARIN IS USED. NO OTHER DRUG WAS USED. THE DOCTOR SUSPECTED THAT THE COATING HAD PEELED OFF. THEY DID NOT NOTICE THE THROMBUS DURING CAG, IT WAS 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 HAD PARALYSIS IN THE AREA BEYOND HIS LEFT WRIST, WHEN DISCHARGED THEIR SYMPTOMS OTHER THAN THE THUMB RECOVERED. THE PATIENT WAS DISCHARGED. CURRENTLY, THE PARALYSIS OF THE THUMB REMAINS, SO OUTPATIENT REHABILITATION WAS 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

    PATIENT IDENTIFIER - REQUESTED, NOT PROVIDED. AGE & DATE OF BIRTH - REQUESTED, NOT PROVIDED. PATIENT SEX - REQUESTED, NOT PROVIDED. WEIGHT - REQUESTED, NOT PROVIDED. ETHNICITY - REQUESTED, NOT PROVIDED. RACE - REQUESTED, NOT PROVIDED. DATE OF EVENT: REQUESTED, NOT PROVIDED. 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 9681834-2020-00217. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    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
    1197061 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 45 ML| MEDIKIT 5FR 25CM SHEATH| TERUMO 0.035RADIFOCUS 150CM| TERUMO ANGIOGRAPHIC CATHETER RF-XL95110L| MEDIKIT 5FR 25CM SHEATH| TERUMO ANGIOGRAPHIC CATHETER RF-XL95110L