BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6639861 · Received June 14, 2017

    Report

    Report Number
    9673241-2017-00469
    Event Type
    Injury
    Date Received
    June 14, 2017
    Date of Event
    May 22, 2017
    Report Date
    May 22, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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: REPROCESSED SOUNDSTAR CATHETER (MODEL# UNKNOWN, LOT# 1974225), REPROCESSED DECA CATHETER (MODEL# UNKNOWN LOT# 1933741), ST. JUDE MEDICAL SWARTZ LAMP SHEATH (MODEL# UNKNOWN LOT# UNKNOWN), CARTO 3 SYSTEM (MODEL# M-4800-01 SERIAL# (B)(4)), SMARTABLATE GENERATOR (MODEL# M-4900-07 SERIAL# (B)(4)), SMARTABLATE PUMP (MODEL# M-4900-08 SERIAL# (B)(4)). MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 1

    THE (B)(4) FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 07/27/2017. 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. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR IDIOPATHIC VENTRICULAR TACHYCARDIA WITH A THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. THE RETURNED DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THE CATHETER WAS EVALUATED FOR CARTO 3 FUNCTIONALITY AND IT WAS RECOGNIZED BY THE SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. THE CATHETER WAS EVALUATED FOR SCREENING TEST AND CATHETER PASSED. THE FORCE FEATURE WAS WORKING PROPERLY. FINALLY, THE FORCE SENSOR VALUES WERE FOUND WITHIN SPECIFICATIONS. THEN THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. ADDITIONALLY, A DEFLECTION AND AN IRRIGATION TEST WERE PERFORMED AND THE CATHETER PASSED THE TESTS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR IDIOPATHIC VENTRICULAR TACHYCARDIA WITH A THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE MAPPING PHASE, A TAMPONADE WAS CONFIRMED VIA ECHOCARDIOGRAM. PERICARDIOCENTESIS WAS PERFORMED AND YIELDED 200ML OF FLUID. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE ANATOMY THAT WAS DIFFICULT TO NAVIGATE. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO OPERATOR ERROR WHILE MANIPULATING THE SMARTTOUCH CATHETER AND SHEATH IN THE CORONARY SINUS. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. SHEATH USED WAS A ST. JUDE MEDICAL SWARTZ LAMP. GENERATOR WAS SET ON POWER CONTROL MODE WITH DEFAULT THRESHOLDS FOR THERMOCOOL SMARTTOUCH CATHETERS. THERE IS NO INFORMATION REGARDING GENERATOR SETTINGS OR POWER TITRATION. OVERALL ABLATION TIME AND LAST ABLATION CYCLE TIME AT THE SITE OF INJURY WERE NOT REPORTED, AS NO ABLATION WAS PERFORMED AT THE SITE OF INJURY. IRRIGATED CATHETER FLOW WAS SET AT 2ML/MIN. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME MAINTAINED BETWEEN 300-350 SECONDS. SPI VALUE WAS REPORTED AS ¿SH¿ (UNDEFINED). 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. 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
    421622 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S 17642356M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R