BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 2831413 · Received November 14, 2012

    Report

    Report Number
    2029046-2012-00153
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 19, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO REQUEST FOR THE COMPLAINT PRODUCT TO BE RETURNED FOR ANALYSIS. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AS INITIALLY REPORTED. NO LOT NUMBER WAS PROVIDED FOR THE DEVIDE THEREFORE NO DEVICE HISTORY RECORD COULD BE REVIEWED.(B)(4).

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: CARTO 3 MODEL # M-4800-01, SERIAL # (B)(4). STOCKERT MODEL # M-5463-01 , SERIAL # (B)(4). COOLFLOW PUMP MODEL # M-5491-02 , SERIAL # (B)(4). LASSO MODEL # UNKNOWN, LOT # UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    BIOSENSE (B)(4) CLINICAL ACCOUNT SPECIALIST WAS NOTIFIED ON (B)(6) 2012 (MARKING THIS DATE AS THE ALERT DATE FOR THIS REPORT) THAT POST AN AFIB PROCEDURE ON (B)(6) 2012 THE PATIENT DEVELOPED EFFUSION BUT WAS DISCHARGED TO HOME WITHOUT ANY MEDICAL INTERVENTION; LATER, HE WAS READMITTED WITH CHEST PAIN AND PERICARDIAL EFFUSION ON (B)(6) TO ANOTHER FACILITY. THE PATIENT WAS PLANNED TO HAVE A CARDIAC CATHETERIZATION. IT WAS UNKNOWN IF A PERICARDIOCENTESIS WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1318-03-S UNKNOWN_D-1318-03-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O