BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3910167 · Received July 2, 2014

    Report

    Report Number
    2029046-2014-00185
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. CONCOMITANT PRODUCTS: STOCKERT GENERATOR: (SERIAL AND MODEL NUMBER UNK). CARTO 3 SYSTEM: (SERIAL AND MODEL NUMBER UNK). (B)(4). LOT NUMBER: UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED PERICARDIOCENTESIS. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. DURING ABLATION IN THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT), THE PHYSICIAN HEARD A STEAM POP. THE PATIENT WAS FOUND TO HAVE A CARDIAC TAMPONADE AS CONFIRMED BY ECHO, AND IT WAS REPORTED THAT THE PATIENT BRIEFLY LOSS CONSCIOUSNESS. THE PROCEDURE WAS ABORTED AND THE PATIENT REQUIRED A PERICARDIAL DRAIN AND AN OVERNIGHT STAY IN THE CRITICAL CARE UNIT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME THE COMPLAINT WAS REPORTED. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION FOR THE CAUSE OF THIS ADVERSE EVENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE PRODUCT HAS NOT BEEN RETURNED. THE PRODUCT INVESTIGATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386464 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1317-05-S UNKNOWN_D-1317-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R