BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIAC CATHETER

    MDR report key: 17453507 · Received August 2, 2023

    Report

    Report Number
    MW5120540
    Event Type
    Injury
    Date Received
    August 2, 2023
    Date of Event
    July 5, 2023
    Report Date
    July 31, 2023
    Manufacturer
    JAPAN LIFELINE CO., LTD.
    Product Code
    DRA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) APEX WAS PERFORATED BY RV CATHETER (MANUFACTURED BY JLL). PERICARDIAL DRAINAGE WAS PERFORMED, AND THE PATIENT WAS TRANSPORTED TO (B)(6) HOSPITAL (ANOTHER HOSPITAL). OPEN CHEST SURGERY WAS CONDUCTED AT ANOTHER HOSPITAL. NO CARDIOPULMONARY BYPASS WAS USED. A PERFORATION SITE WAS SUTURED, AND THE PATIENT WAS STABLE. ATRIAL SEPTAL PUNCTURE WAS NOT PERFORMED. ABLATION WAS NOT PERFORMED BEFORE PERICARDIAL EFFUSION OR TAMPONADE WAS CONFIRMED. STEAM POP WAS NOT CONFIRMED. THE PROCEDURE WAS FOR A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773204 CARDIAC CATHETER CATHETER, STEERABLE DRA JAPAN LIFELINE CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown