BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACEL BIPOLAR PACING CATH 6F RHC

    MDR report key: 2994339 · Received March 1, 2013

    Report

    Report Number
    2182269-2013-00010
    Event Type
    Injury
    Date Received
    March 1, 2013
    Report Date
    February 14, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    K772197
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. 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 INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE PACAL BIPOLAR PACING CATHETER INSTRUCTIONS FOR USE (IFU) STATES THAT POTENTIAL ADVERSE EFFECTS MAY BE ASSOCIATED WITH THE PACAL BIPOLAR PACING CATHETER. THESE INCLUDE ARRYTHMIAS, CARDIAC PERFORATION, CARDIAC TAMPONADE, AND DAMAGE TO VESSEL OR VALVE STRUCTURES.

    Description of Event or Problem · 1

    A 6F BIPOLAR PACING CATHETER WAS SELECTED FOR USE. DURING AN EXTERNAL PACEMAKER PROCEDURE, WHILE MANEUVERING THE PACEL THROUGH THE INTRODUCER AND INTO PLACE IN THE PATIENT'S HEART, A SMALL PERFORATION OCCURRED. THE PATIENT PERFORMED A SUCCESSFUL PERICARDIOCENTESIS AND THE PATIENT WAS STABILIZED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, WITH NO NEED FOR AN EXTENDED STAY. THE PHYSICIAN STATED THAT THIS EVENT WAS NOT DUE TO THE PACEL DEVICE MALFUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89024 PACEL BIPOLAR PACING CATH 6F RHC ELECTRODE, PACEMAKER, TEMPORARY DTB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention