BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLO INTRODUCER

    MDR report key: 3872044 · Received April 15, 2014

    Report

    Report Number
    3005188751-2014-00057
    Event Type
    Injury
    Date Received
    April 15, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 21, 2014
    Manufacturer
    ST. JUDE MEDICAL (AF-MINNETONKA)
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS . A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE 3005188751-2014-00055, 3005188751-2014-00056. DURING A CARDIAC ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BRK TRANSSEPTAL NEEDLE AND TWO UNKNOWN SJM SLO INTRODUCERS WERE PLACED IN THE HEART. WHILE MAPPING IN THE LEFT ATRIUM WITH A NON-SJM F-CURVE ABLATION CATHETER, TRANSEPTAL ACCESS WAS LOST. THE PHYSICIAN THEN INSERTED A NON-SJM D-CURVE CATHETER AND THE PATIENT BECAME HYPOTENSIVE. ULTRASOUND REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED, WHICH STABILIZED THE PATIENT. FURTHER INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230289 SLO INTRODUCER DYB ST. JUDE MEDICAL (AF-MINNETONKA) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 SLO INTRODUCTER (MODEL/LOT UNK)| BRK TRANSSEPTAL NEEDLE (MODEL/LOT UNK)| BIOSENSE WEBSTER D-CURVED CATHETER(MODEL/LOT UNK)| BIOSENSE WEBSTER F-CURVED CATHETER (MODLE/LOT UNK)