BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3520143 · Received December 16, 2013

    Report

    Report Number
    9673241-2013-00446
    Event Type
    Injury
    Date Received
    December 16, 2013
    Date of Event
    November 26, 2013
    Report Date
    November 26, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P990025/S12
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: CARTO 3 SYSTEM (SERIAL # (B)(4)) AND STOCKERT, SERIAL # (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF # (B)(4). IT WAS REPORTED THAT THE PATIENT'S HEART RATE WENT UP AND THE BLOOD PRESSURE DROPPED DURING THE CASE AFTER A STEAM POP WHICH RESULTED TO PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 800-900 CC OF FLUID WAS REMOVED THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. THE CATHETER WAS ALSO EVALUATED FOR EEPROM, CARTO 3, 4 KHZ AND CALIBRATION FUNCTIONALITY. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. FINALLY, A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. 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. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE PERICARDIAL EFFUSION REMAINS UNKNOWN. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AFIB ¿ PAROXYSMAL PROCEDURE, THE PATIENT'S HEART RATE WENT UP AND THE BLOOD PRESSURE DROPPED DURING THE CASE AFTER A STEAM POP WHICH RESULTED TO PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 800-900 CC OF FLUID WAS REMOVED. THE PATIENT LEFT THE EP LAB WITH THE EFFUSION UNDER CONTROL AND VITAL SIGNS STABLE BUT SHE WAS INTUBATED. EXPECTED TO REMOVE BREATHING TUBE LATER. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF THE PERFORATION/TAMPONADE WAS THE TEMPERATURE ROSE TO 58 DEGREES CELSIUS CAUSED THE STEAM POP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656074 EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1268-05-S 15960315M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R