BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDECATH

    MDR report key: 10269762 · Received July 14, 2020

    Report

    Report Number
    9681834-2020-00128
    Event Type
    Injury
    Date Received
    July 14, 2020
    Date of Event
    June 17, 2020
    Report Date
    July 14, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQO
    PMA / PMN Number
    K090040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 510(K): K915414. (B)(4). THE INVOLVED DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE INVESTIGATION WAS BASED ON USER FACILITY INFORMATION AND EVALUATION OF THE RETENTION SAMPLE. VISUAL INSPECTION OF THE RETENTION SAMPLE FROM THE INVOLVED PRODUCT CODE/LOT# COMBINATION REVEALED THAT THE WERE NO ANOMALIES, INCLUDING A KINK OR CRUSH, OVER THE ENTIRE LENGTH. THE OUTER AND INNER DIAMETER WERE MEASURED AND CONFIRMED TO MEET THE MANUFACTURER SPECIFICATIONS. THE TAPERED PART OF THE TWO-WAY STOPCOCK WAS MEASURED, AND NO ANOMALY WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORDS OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. THE INVESTIGATION RESULTS VERIFIED THAT THE RETENTION SAMPLE WAS NORMAL PRODUCT. HOWEVER, WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE INVOLVED RADIFOCUS GLIDECATH AND A PREDURA THREE-WAY STOPCOCK (TOP) WERE USED FOR CEREBRAL ANGIOGRAPHY. THE PROCEDURE WAS PERFORMED IN THE USUAL WAY AND FINISHED WITHOUT ANY PROBLEM. AFTER THE PROCEDURE WAS FINISHED, THE PATIENT HAD ANOMALY AND DEVELOPED APHASIA. THE POSSIBILITY CANNOT BE RULED OUT THAT APHASIA HAD DEVELOPED BEFORE THE PROCEDURE. AT THE TIME OF PRE-PROCEDURE ID CHECK, THE PATIENT COULD NOT RESPOND VERBALLY TO THE QUESTIONS, AND RESPONDED BY NODDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733495 RADIFOCUS GLIDECATH CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO TERUMO CORPORATION, ASHITAKA NA 190107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other