BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 6424426 · Received March 22, 2017

    Report

    Report Number
    9673241-2017-00227
    Event Type
    Injury
    Date Received
    March 22, 2017
    Date of Event
    February 23, 2017
    Report Date
    February 24, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835010176
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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: SOUNDSTAR CATHETER. SMARTABLATE GENERATOR. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BI-DIRECTIONAL SF CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. THE RETURNED DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND GENERATOR TEST AND IT WAS FOUND WITHIN SPECIFICATIONS. A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. THE CATHETER WAS EVALUATED FOR EEPROM, AND THE FUNCTIONALITY OF THE SENSORS OF THE CATHETER WERE TESTED ON THE CARTO 3 SYSTEM. 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. THE FORCE FEATURES WAS EVALUATED AND PASSED. AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER PASSED, NO OCCLUSION WAS OBSERVED. 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 CARDIAC TAMPONADE REMAINS UNKNOWN. THE INSTRUCTIONS FOR USE STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE.

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON (B)(6) 2017. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BI-DIRECTIONAL SF CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA SOUNDSTAR CATHETER AND ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AND YIELDED 350-400 CC OF FLUID. PATIENT WAS REPORTED TO BE IN STABLE CONDITION UPON LEAVING THE LAB WITH NO PERICARDIAL EFFUSION. PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT OVERNIGHT FOR OBSERVATION AND REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT OUTCOME IS IMPROVED. THERE WERE NO FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT HE WAS ABLATING AT HIGH FORCE VALUES IN CONJUNCTION WITH NAVIGATING WITH THE AGILIS SHEATH IN ORDER TO DIRECT THE ABLATION CATHETER. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK NEEDLE. SHEATH IN USE WAS A AGILIS ST. JUDE MEDICAL 8.5 FRENCH. GENERATOR PARAMETERS INCLUDED POWER CONTROL MODE WITH TEMPERATURE CUT-OFF OF 43°C. GENERATOR SETTINGS, OVERALL ABLATION TIME, AND LAST ABLATION CYCLE TIME AT THE SITE OF INJURY WERE NOT REPORTED, AS THE INFORMATION IS UNAVAILABLE. IRRIGATED CATHETER FLOW WAS SET AT 15 ML/MIN. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME MAINTAINED BETWEEN 300-350 SECONDS. SMARTTOUCH CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER. CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE POST CATHETER CONNECTION TO THE CARTO® 3 PATIENT INTERFACE UNIT. CARTO® 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. THERE WERE NO ERRORS REPORTED ON ANY BWI EQUIPMENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206458 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-04-S 17576592L 10846835010176

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R