BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    WALRUS 087 BALLOON GUIDE CATHETER

    MDR report key: 19235472 · Received May 2, 2024

    Report

    Report Number
    3015614180-2024-00006
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    March 15, 2024
    Report Date
    May 2, 2024
    Manufacturer
    Q'APEL MEDICAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K192525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF MW5153004 THAT WAS ISSUED HAD THE FOLLOWING ERRORS OBSERVED: BRAND NAME- HORMONAL REPLACEMENT THERAPY REPORT SENT TO FDA? N. 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 4/4/2024, Q'APEL MEDICAL RECEIVED AN EMAIL FROM THE FDA NOTIFYING THE COMPANY OF A VOLUNTARY MDR THAT WAS SUBMITTED ON (B)(6) 2024. PER THE REPORTED PROBLEM STATEMENT: "WALRUS BALLOON GUIDE CAUSING DISSECTION OF CERVICAL INTERNAL CAROTID ARTERY AT LEVEL OF BALLOON INFLATION, AS WELL AS SEVERE VASOSPASM, WITH EXTRAVASATING HEMORRHAGE REQUIRING COVERED STENT PLACEMENT." 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
    1030065 WALRUS 087 BALLOON GUIDE CATHETER CATHETER INTRODUCER, DQY Q'APEL MEDICAL INC. 087 BALLOON GUIDE CATHETER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other