BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 6502452 · Received April 18, 2017

    Report

    Report Number
    9673241-2017-00296
    Event Type
    Injury
    Date Received
    April 18, 2017
    Date of Event
    March 29, 2017
    Report Date
    March 29, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    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. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM. LASSO CATHETER. ST. JUDE MEDICAL BRK-1 TRANSSEPTAL NEEDLE, MODEL # 407207, LOT # 5771253. ST. JUDE MEDICAL AGILIS 8.5FR SHEATH. (B)(4). THERE IS NO INFORMATION REGARDING SPI VALUE. SMARTTOUCH CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER. SMARTTOUCH CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE POST CATHETER CONNECTION TO THE CARTO® 3 PATIENT INTERFACE UNIT. PHYSICIAN EXCHANGED THE ABLATION CATHETER FOR A LASSO CATHETER DURING THE CASE. PHYSICIAN RE-ZEROED EACH TIME AFTER ADVANCING THE THERMOCOOL SMARTTOUCH BI-DIRECTIONAL SF CATHETER BACK INTO THE SHEATH. THERE WERE NO ERROR MESSAGES OBSERVED ON ANY BWI EQUIPMENT DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) WITH WIDE AREA CIRCUMFERENTIAL ABLATION (WACA) PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BI-DIRECTIONAL SF CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND PERICARDIAL DRAIN. DURING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAM. PERICARDIOCENTESIS YIELDED 300 ML. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THIS ADVERSE EVENT. PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THERE WERE NO FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. IT WAS PRESUMED THAT THE INJURY OCCURRED DURING ABLATION PHASE. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK-1 TRANSSEPTAL NEEDLE. SHEATH IN USE WAS A ST. JUDE MEDICAL AGILIS 8.5 FRENCH. GENERATOR WAS SET ON POWER CONTROL MODE. POWER WAS NOT TITRATED. GENERATOR PARAMETERS AND SETTINGS AT THE TIME OF INJURY WERE NOT REPORTED, AS THE TIME OF INJURY IS UNKNOWN. OVERALL ABLATION TIME AND LAST ABLATION CYCLE TIME AT THE SITE OF INJURY WAS NOT REPORTED, AS THE SITE OF INJURY IS UNKNOWN. IRRIGATED CATHETER FLOW WAS SET ON 2 ML/MIN WHILE MAPPING, 8 ML/MIN WHILE ABLATING AT LESS THAN 30 WATTS, AND 15 ML/MIN WHILE ABLATING AT 30 WATTS OR GREATER. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME MAINTAINED AT 350 SECONDS OR GREATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283594 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-05-S 17616283L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R