BEUDAMED
    FDA Adverse Event Injury Summary report: N

    087 BALLOON GUIDE CATHETER

    MDR report key: 11402017 · Received March 2, 2021

    Report

    Report Number
    3015614180-2021-00044
    Event Type
    Injury
    Date Received
    March 2, 2021
    Report Date
    March 2, 2021
    Manufacturer
    QAPEL MEDICAL INC
    Product Code
    DQY
    PMA / PMN Number
    K192525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF THE EVENT ON 2/2/2021 FOLLOWING A RETROSPECTIVE CHART REVIEW RESEARCH STUDY. DISSECTION OCCURRED DURING THE PROCEDURE AFTER SUCCESSFUL THROMBECTOMY. IT WAS NOTED AFTER THE 087 BALLOON GUIDE CATHETER WAS WITHDRAWN INTO THE COMMON CAROTID ARTERY, CERVICAL PROJECTION DEMONSTRATED A DISSECTION OF THE CERVICAL SEGMENT OF THE INTERNAL CAROTID ARTERY WHERE THE BALLOON GUIDE CATHETER HAD BEEN INFLATED. THE PHYSICIAN COMMENTED THAT THE BALLOON WS OVERINFLATED AND MAY HAVE CAUSED THE DISSECTION. THE DISSECTION WAS TREATED WITH BALLOON ANGIOPLASTY AND STENTING. PATIENT HAD A HEMORRHAGIC CONVERSION WITH WORSENING CLINICAL STATUS AND REQUIRED HEMICRANIECTOMY AND EVD PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294704 087 BALLOON GUIDE CATHETER CATHETER INTRODUCER DQY QAPEL MEDICAL INC 087 BALLOON GUIDE CATHETER

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention