BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE

    MDR report key: 17530462 · Received August 12, 2023

    Report

    Report Number
    MW5137381
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    October 2, 2018
    Report Date
    October 29, 2018
    Manufacturer
    MEDTRONIC
    Product Code
    DRA
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS LETTER IS TO INFORMYOU OF THIS ADVERSE EVENT IFRHE SUSPECTECFAEVICE OF MEDTRONIC SHEATH -(4FC'12) FLEXCATHADVANCE 12FR (B)(4) IS NOT MANUFACTURED OR IMPORTED BY BIOSENSE WEBSTER, INC. EVENT DESCRIPTION: TAMPONADE DURING PVL ABLATION WITH CRYOBALON REQUIRING PERICARDIOCENTESIS. ADDITIONAL INFORMATION PROVIDED WAS THAT THE PHYSICIAN'S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. DID NOT RETIRE CORRECTLY THE SHEATH; THEREFORE, MAYBE IT WAS DONE TOO FAST WHICH MIGHT HAVE CAUSED THE INJURY. (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
    1072942 FLEXCATH ADVANCE CATHETER, STEERABLE DRA MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown