BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4241995 · Received November 10, 2014

    Report

    Report Number
    9673241-2014-00471
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BWI PRODUCTS IN USE FOR THE PROCEDURE WERE: CARTO 3 SYSTEM: SER# (B)(4); STOCKERT GENERATOR: SER# ST-(B)(4); COOL FLOW PUMP: SER # (B)(4); SOUNDSTAR CATHETER: CAT# SNDSTR10, LOT# OEM. (B)(4)

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THAT DURING AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED IN WHICH 1000 CC'S WAS REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS STABILIZED AND TRANSFERRED TO THE CCU FOR OBSERVATION. THERE WAS NO APPLICATION ON RF ENERGY DURING THE PROCEDURE. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH AGILIS SHEATH, 11FR SIZE, (B)(4). INJURY OCCURRED DURING THE MAPPING PHASE. NO ERROR MESSAGES WERE SEEN ON THE EQUIPMENT. THE CATHETER WAS IRRIGATED AT THE FLOW AT THE NORMAL MAPPING RATE OF 2CC/MIN AS REQUIRED. THE PHYSICIAN DID NOT BELIEVE THAT A BWI PRODUCT WAS RESPONSIBLE FOR THE INJURY. BWI TAKING CONSERVATIVE APPROACH TO REPORT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722202 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-04-S 16092272M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R