BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DECANAV ELECTROPHYSIOLOGY CATHETER

    MDR report key: 7301807 · Received February 27, 2018

    Report

    Report Number
    2029046-2018-01272
    Event Type
    Injury
    Date Received
    February 27, 2018
    Date of Event
    February 6, 2018
    Report Date
    February 6, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835008807
    PMA / PMN Number
    K080425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON FEBRUARY 23, 2018. THE PATIENT WAS WALKING AROUND THE NEXT DAY ACCORDING TO PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. 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. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM (MODEL# FG540000 SERIAL (B)(4)). MOBICATH (MODEL# D140011 LOT# VN387849). CORONARY SINUS CATHETER (MODEL# BD710DF LOT# 30000194M). SMARTTOUCH SF CATHETER (MODEL# D134804 LOT# 17758958L). SOUNDSTAR CATHETER (MODE# UNKNOWN LOT# UNKNOWN). BOSTON SCIENTIFIC WATCHMAN LEFT ATRIAL APPENDAGE OCCLUSION DEVICE (MODE# UNKNOWN LOT# UNKNOWN). (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ISCHEMIC LEFT VENTRICULAR TACHYCARDIA WITH A DECANAV ELECTROPHYSIOLOGY CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING SURGICAL INTERVENTION. DURING THE PROCEDURE, THE LEFT ATRIAL APPENDAGE (LAA) WAS PERFORATED WITH THE DECANAV CATHETER AND A PERICARDIAL EFFUSION WAS DETECTED. PERICARDIOCENTESIS WAS PERFORMED AND YIELDED 500+ CC OF FLUID AND WAS STILL DRAINING WHEN THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR A SURGICAL REPAIR. PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME OF COMPLAINT REPORT. IT WAS NOTED THAT IMPLANTATION OF A BOSTON SCIENTIFIC WATCHMAN LEFT ATRIAL APPENDAGE OCCLUSION DEVICE WAS ATTEMPTED DURING THE PROCEDURE, BUT WAS UNSUCCESSFUL. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION IN THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143237 DECANAV ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 17727435M 10846835008807

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R