BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 3727422 · Received April 4, 2014

    Report

    Report Number
    2029046-2014-00106
    Event Type
    Injury
    Date Received
    April 4, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 19, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. PRODUCT WAS NOT RETURNED FOR INVESTIGATION AS INITIALLY REPORTED. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT BWI PRODUCTS: CARTO 3 SYSTEM: US CATALOG # FG540000, SERIAL # (B)(4). STOCKERT 70 RF GENERATOR: US CATALOG # S7001, SERIAL # (B)(4). COOLFLOW IRRIGATION PUMP: US CATALOG # UNKNOWN, SERIAL # UNKNOWN. STERILMED PRODUCT: US CATALOG # UNKNOWN, LOT # UNKNOWN. THERE WERE TWO COMPETITOR'S PRODUCTS INVOLVED FROM BARD MEDICAL DIVISION AND ONE COMPETITOR PRODUCT FROM MEDTRONIC. A NOTIFICATION WAS SENT TO EACH MANUFACTURER OF THIS EVENT. SINCE THE LOT # 16005283MA WAS PROVIDED, THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    DURING AN IDIOPATHIC VENTRICULAR TACHYCARDIA PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN WAS CHANGING THE TRANSSEPTAL SHEATH AND NOTICED A PERICARDIAL EFFUSION ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE PATIENT¿S BLOOD PRESSURE DROPPED AND A PERICARDIOCENTESIS WAS PERFORMED. THE STATUS OF THE PATIENT WAS UNKNOWN. ON (B)(6), RECEIVED ADDITIONAL INFORMATION REQUESTED FROM BWI REPRESENTATIVE STATING THAT THE PATIENT REQUIRED HOSPITALIZATION AND THE OUTCOME WAS AN IMPROVEMENT. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF THIS ADVERSE EVENT IS PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204761 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1327-05-S 16005283MA

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| L| R