BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD DIAGNOSTIC WOVEN QUAD CATHETER

    MDR report key: 17528751 · Received August 12, 2023

    Report

    Report Number
    MW5135680
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    August 22, 2014
    Report Date
    September 15, 2014
    Manufacturer
    BARD MEDICAL DIVISION
    Product Code
    DRF
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS LETTER IS TO INFORM YOU OF THIS ADVERSE EVENT AS THE SUSPECT DEVICE (BARD MEDICAL DIVISION -BARD DIAGNOSTIC WOVEN QUAD CATHETER) IS NOT MANUFACTURED OR IMPORTED BY BIOSENSE WEBSTER, INC. IT WAS REPORTED THAT THE PATIENT SUFFERED A PERICARDIAL EFFUSION. DURING THE PROCEDURE THE PATIENT'S PRESSURE DROPPED AND THEY BECAME NAUSEOUS AND COMPLAINED OF CHEST PAIN. THE ICS CATHETER CONFIRMED A PERICARDIAL EFFUSION AND PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT IS STABLE AT THIS TIME AND NO FURTHER INTERVENTION IS ANTICIPATED. THE PHYSICIAN STATED THAT THE RV WAS PERFORATED BY THE RV DIAGNOSTIC CATHETER. THE CARTO 3 SYSTEM (11854), STOCKERT 70 (ST-0308), AND COOLFLOW PUMP (05047) WERE UTILIZED IN THE PROCEDURE. THE CALLER ALSO STATED THAT THE ICE CATHETER WAS FROM STRYKER, AND THE RV CATHETER WAS A BARD DIAGNOSTIC WOVEN QUAD CATHETER. (B)(4). 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
    562932 BARD DIAGNOSTIC WOVEN QUAD CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BARD MEDICAL DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown