BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    WALRUS 087 BALLOON GUIDE CATHETER

    MDR report key: 19602376 · Received June 24, 2024

    Report

    Report Number
    3015614180-2024-00008
    Event Type
    Injury
    Date Received
    June 24, 2024
    Date of Event
    April 25, 2024
    Report Date
    June 20, 2024
    Manufacturer
    Q'APEL MEDICAL INC.
    Product Code
    DQY
    UDI-DI
    00857545008028
    PMA / PMN Number
    K192525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO THE LIMITED INFORMATION, Q'APEL MEDICAL IS UNABLE TO CONFIRM THE REPORTED EVENT AND DETERMINE IF A PRODUCT MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    ON 5/28/2024, Q'APEL MEDICAL RECEIVED AN EMAIL FROM THE FDA NOTIFYING THE COMPANY OF A VOLUNTARY MDR THAT WAS SUBMITTED ON 5/5/2024. PER THE REPORTED PROBLEM STATEMENT: "CERVICAL LEFT INTERNAL CAROTID ARTERY DISSECTION AT SITE OF WALRUS BALLOON GUIDE CATHETER INFLATION WITH CONTRAST POOLING IN FALSE LUMEN, CREATING FUSIFORM DILATION AND REQUIRING ANTIPLATELET USE (ASPIRIN) TO PREVENT THROMBOEMBOLISM. THIS OCCURRED AFTER MECHANICAL THROMBECTOMY FOR INTRACRANIAL LARGE-VESSEL OCCLUSION (LEFT MIDDLE CEREBRAL ARTERY OCCLUSION). 95-CM 8F WALRUS BGC." THE LOCATION PROVIDED WAS THE USA. NO OTHER INFORMATION WAS PROVIDED IN THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103393 WALRUS 087 BALLOON GUIDE CATHETER CATHETER INTRODUCER DQY Q'APEL MEDICAL INC. 087 BALLOON GUIDE CATHETER 00857545008028

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Congenital Anomaly| R