BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 3844488 · Received June 3, 2014

    Report

    Report Number
    9673241-2014-00214
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 12, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    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. BWI PRODUCTS IN USE FOR THE PROCEDURE WERE: CARTO 3 SYSTEM: SERIAL # (B)(4). STOCKERT GENERATOR: SERIAL # (B)(4). COOL FLOW PUMP: SERIAL # (B)(4). LASSO CATHETER: CAT# D134302, LOT# 16023277L. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, LEFT PULMONARY VEINS DONE & ISOLATED, 80% OF RIGHT PVI LINE DONE. THE PHYSICIAN NOTED LESS CARDIAC MOTION ON XRAY, THE BLOOD PRESSURE 80-90 RANGE, USED ICE CATHETER AND QUICKLY IDENTIFIED PERICARDIAL EFFUSION. THE PHYSICIAN WAS UNSURE IF THIS HAPPENED DURING ABLATION OR SIMPLY CATHETER MANIPULATION (SOME CONCERN OF MANIPULATION WITH ABLATION CATHETER BARELY OUT OF SHEATH CREATING ADDED STIFFNESS ON OCCASION). NO STEAM POP OR CONCERN FOR DEVICE MALFUNCTION VERBALIZED BY THE PHYSICIAN. THE CASE WAS ABORTED IMMEDIATELY, HEPARIN REVERSED, ALL CATHETERS REMOVED FROM LEFT ATRIUM. THE PATIENT MONITORED CLOSELY AT THEY SET UP FOR PERICARDIOCENTESIS. TRANSTHORACIC ECHO AND THEN EFFUSION DRAINED FOR APPROXIMATELY 340 CC BLOODY FLUID. THE BLOOD PRESSURE NEVER DROPPED BELOW 80¿S. THE PATIENT TRANSFERRED TO THE CCU FOR OBSERVATION. THE PHYSICIAN/CUSTOMER¿S OPINION REGARDING THE CAUSALITY OF ADVERSE EVENT WAS PROCEDURE-RELATED (CATHETER MANIPULATION BY FELLOW).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323842 NAVISTAR® THERMOCOOL® CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1197-16-S 16039456M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R