BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 3853192 · Received June 6, 2014

    Report

    Report Number
    2029046-2014-00159
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: LASSO NAVIGATIONAL VARIABLE ECO CATHETER, MODEL #: D-1343-02-S, LOT #: 16044550L. SOUNDSTAR CATHETER, MODEL #: M-5723-05, LOT # 80146835000139. DECA NAVIGATIONAL CATHETER, MODEL #: D-1285-02-S, LOT #: 16054160M. CARTO 3 SYSTEM, MODEL #: M-4800-01, SERIAL #: (B)(4). STOCKERT 70 SYSTEM, MODEL #: M-5463-01, SERIAL #: (B)(4). COOLFLOW PUMP, MODEL #: M-5491-02, SERIAL #: (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. 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. MANUFACTURER'S REF. NO.: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SMART TOUCH UNIDIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE AND A STEAM POP, WHICH REQUIRED SURGICAL INTERVENTION. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. THE PATIENT SUFFERED THE CARDIAC TAMPONADE DURING ABLATION OF THE RIGHT ATRUIM (RA). THE PHYSICIAN HAD COMPLETED ABLATION OF THE PULMONARY VEINS IN THE LEFT ATRIUM (LA) BEFORE RETURNING TO THE RA TO ABLATE. A STEAM POP WAS HEARD DURING ABLATION OF THE TRICUSPID ISTHMUS NEAR THE CORONARY SINUS AND THE BLOOD PRESSURE CUFF WAS RECYCLED. THE BLOOD PRESSURE DROPPED AFTER ABOUT 3-5 MINUTES AFTER THE STEAM POP. THE CARDIAC TAMPONADE WAS NOTED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE PROCEDURE WAS STOPPED. A PERICARDIOCENTESIS WAS THEN ATTEMPTED WITHOUT SUCCESS. THE PATIENT LEFT THE EP LAB STABLE AND WENT TO SURGERY. THE SURGERY WAS SUCCESSFUL. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME THE COMPLAINT WAS REPORTED AND WAS HELD FOR OBSERVATION ACCORDING TO HOSPITAL PROTOCOLS. THERE IS NO FURTHER INFORMATION ABOUT THE HOSPITALIZATION. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION FOR THE CAUSE OF THIS ADVERSE EVENT. PER 21 CFR, PART 803, THIS COMPLAINT IS REPORTABLE. 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332560 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1336-01-S 16039593MA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R