BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE WIRE ACC. KT W/COPILOT

    MDR report key: 329856 · Received April 27, 2001

    Report

    Report Number
    2024168-2001-00125
    Event Type
    Malfunction
    Date Received
    April 27, 2001
    Date of Event
    March 30, 2001
    Report Date
    March 30, 2001
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    DTL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE, AN AIR EMBOLISM OCCURRED IN THE CORONARY DURING THE USE OF A COPILOT, RESULTING IN A SHORT 15 SECOND AV BLOCK. NO TREATMENT WAS ADMINISTERED TO TREAT THE AV BLOCK, AND THE PROCEDURE WAS COMPLETED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19413 GUIDE WIRE ACC. KT W/COPILOT GUIDE WIRE ACCESSORY KIT DTL GUIDANT VASCULAR INTERVENTION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN