BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 3243001 · Received July 23, 2013

    Report

    Report Number
    9673241-2013-00249
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 9, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS STATED BY THE CUSTOMER THAT THE PRODUCT HAD BEEN DISCARDED THUS PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED; THE DHR REVIEW VERIFIES THAT THE DEVICES WERE MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CONCOMITANT PRODUCTS: CARTO 3 MODEL# M-4800-01, SERIAL # (B)(4); STOCKERT MODEL# M-5463-01, SERIAL # UNKNOWN; COOLFLOW PUMP MODEL# M-5491-02, SERIAL # UNKNOWN; LASSO MODEL # UNKNOWN, LOT# UNKNOWN (CUSTOMER DISPOSED OF); WEBSTER 4 POLE MODEL # UNKNOWN, LOT# UNKNOWN (CUSTOMER DISPOSED OF). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TOWARDS THE END OF AN ATRIAL FIBRILLATION (AFIB) CASE, THE PATIENT'S BLOOD PRESSURE DROPPED. X-RAY CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343007 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1315-01-S 15784144L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R