BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSSEPTAL NEEDLE, BRK 1, 71CM

    MDR report key: 1410743 · Received July 2, 2009

    Report

    Report Number
    3005188751-2009-00033
    Event Type
    Other
    Date Received
    July 2, 2009
    Date of Event
    June 29, 2009
    Report Date
    June 29, 2009
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING RETURN OF THE DEVICE. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT DEVELOPED A PERICARDIAL EFFUSION DURING AN AF PROCEDURE. TWO TRANSSEPTALS WERE COMPLETED WITH SJM SHEATHS. WITH THE ABLATION CATHETER AND SPIRAL OPTIMA CATHETER IN THE LEFT ATRIUM, THE PT'S PRESSURE FELL FOLLOWING TRANSSEPTAL PUNCTURE. NO ABLATION WAS PERFORMED ON THE PT. THE PHYSICIAN BELIEVES THE LAA WAS PUNCTURED. IT IS UNK IF INTERVENTION WAS REQUIRED TO STOP THE BLEEDING. NO INDICATION WAS GIVEN AS TO WHICH DEVICE CAUSED THE PUNCTURE. THE FOLLOWING DEVICES WERE USED DURING THE PROCEDURE, SJM INTRODUCER SHEATH (406840, LOT 2748226), IBI OPTIMA CATHETER (81687, LOT K12107), IBI COOL PATH CATHETER (83503, LOT K07903), SJM SL1 SHEATH (407453, LOT 2765528), SJM CS CATHETER (401864, LOT 2768587), AND A SJM QUAD (401450, LOT 2771777).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSSEPTAL NEEDLE, BRK 1, 71CM BRK NEEDLE DRC ST. JUDE MEDICAL, AF DIVISION 407201 2725019

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other