BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOGA-STAR TM CARDIOLOGY CATHETER

    MDR report key: 1738878 · Received June 28, 2010

    Report

    Report Number
    2029046-2010-00028
    Event Type
    Injury
    Date Received
    June 28, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 2, 2010
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    K954390
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) THIS EVENT OCCURRED WITHIN AN (B) (4) STUDY WHICH IS A PHASE II DOSE-ESCALATION STUDY TO ASSESS THE FEASIBILITY AND SAFETY OF TRANSENDOCARDIAL DELIVERY OF THREE DIFFERENT DOSES OF ALLOGENEIC MESENCHYMAL PRECURSOR CELLS (MPCS)IN SUBJECTS WITH HEART FAILURE WHICH IS SPONSORED BY ANGIOBLAST SYSTEMS. THE MYOSTAR INJECTION CATHETER IS NOT APPROVED FOR USE IN THE UNITED STATES. CONCOMITANT PRODUCTS USED DURING THE PROCEDURE: NOGA XP SYSTEM: MODEL NO.: M-5724-01 (B) (4). MYOSTAR INJECTION CATHETER: MODEL NO.: D-1211-19-SI LOT NO.: 13409366. EXTERNAL REFERENCE PATCH: MODEL NO.: D-1210-03 LOT NO.: 15043790.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 20 MINUTES AFTER THE CASE, THE PATIENT WAS SLIGHTLY HYPOTENSIVE. AN ECHO REVEALED A PERICARDIAL EFFUSION. THIS WAS DRAINED AND A PERICARDIAL CATHETER WAS PUT IN PLACE AND WAS REMOVED ON (B) (6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOGA-STAR TM CARDIOLOGY CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC (IRWINDALE) 120707S 13424627A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R