BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6637725 · Received June 13, 2017

    Report

    Report Number
    9673241-2017-00455
    Event Type
    Injury
    Date Received
    June 13, 2017
    Date of Event
    May 17, 2017
    Report Date
    May 17, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835009194
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION CONTINUATION: ON THE LEFT SIDE PRIOR TO THE ADVERSE EVENT. THERE WAS NO INFORMATION REGARDING IRRIGATED CATHETER FLOW SETTING. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME MAINTAINED BETWEEN 300-350 SECONDS. IT WAS NOTED THAT NO OTHER BIOSENSE WEBSTER, INC. CATHETERS WERE OPENED. THERE WAS NO INFORMATION REGARDING SHAFT PROXIMITY INTERFERENCE VALUE, CATHETER PROXIMITY, OR CATHETER ZEROING. THERE WERE NO ERRORS REPORTED ON ANY BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE PROCEDURE. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. 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. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER17651261M HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. CONCOMITANT PRODUCTS: 1.CARTO 3 SYSTEM, MODEL #:M-4800-01, SERIAL #: (B)(4). 2.SMARTABLATE GENERATOR MODEL #: M-4900-07 SERIAL #: (B)(4). 3.SMARTABLATE PUMP MODEL #: M-4900-08 SERIAL #: (B)(4). 4.NON BIOSENSE WEBSTER, INC. - BAYLIS MEDICAL TRANSSEPTAL NEEDLE. 5.NON BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL BRK-1 TRANSSEPTAL NEEDLE. 6.NON BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL SL1 SHEATH. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 6/30/17. 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

    ADDITIONAL INFORMATION WAS RECEIVED ON JULY 12, 2017, CLARIFYING THAT THE EXTRA PRODUCT RECEIVED (SMART TOUCH BIDIRECTIONAL CATHETER / MODEL #: D-1327-04-S / LOT #: 17651261M) WAS SENT IN ERROR TO THE BIOSENSE WEBSTER FAILURE ANALYSIS LAB. IT WAS CLARIFIED THAT THIS SECOND PRODUCT WAS TAKEN OUT OF THE PACKAGE. HOWEVER, IT WAS NOT USED IN THE PATIENT AS THE PATIENT EVENT OCCURRED PRIOR TO PLACING IT IN THE PATIENT¿S BODY. SINCE THE PRODUCT INFORMATION FOR THE SECOND CATHETER IS THE SAME AS THE FIRST CATHETER REPORTED AND WE WERE UNABLE TO IDENTIFY WHICH PRODUCT WAS NOT USED IN THE PATIENT, WE HAVE ALSO ANALYZED THIS PRODUCT. BELOW IS THE COMPLETED INVESTIGATIONAL ANALYSIS FOR THIS EXTRA PRODUCT RECEIVED: THE RETURNED DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THE CATHETER WAS EVALUATED FOR CARTO 3 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. EVALUATION CODES WERE THE SAME FOR BOTH PRODUCTS. (B)(4). IT WAS REPORTED THAT A FEMALE PATIENT, IN HER MID-60S, UNDERWENT AN ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BIDIRECTIONAL NAVIGATION CATHETER. DURING TRANSSEPTAL PUNCTURE, WHICH REQUIRED MULTIPLE ATTEMPTS, THE PHYSICIAN FELT A POP. ONCE THE ABLATION CATHETER WAS ADVANCED INTO THE LEFT ATRIUM, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA ULTRASOUND. CATHETERS WERE PULLED. PERICARDIOCENTESIS YIELDED 600 ML. PATIENT WAS TRANSFERRED TO THE CORONARY CARE UNIT (CCU). PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT OUTCOME WAS IMPROVED. THE PATIENT HAD THE ABLATION PROCEDURE AT SOME POINT (UNSPECIFIED) AFTER THE PERICARDIAL DRAIN WAS PLACED. THE RETURNED DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THE CATHETER WAS EVALUATED FOR CARTO 3 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 FEMALE PATIENT, IN HER MID-60S, UNDERWENT AN ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BIDIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND PERICARDIAL DRAIN. DURING TRANSSEPTAL PUNCTURE, WHICH REQUIRED MULTIPLE ATTEMPTS, THE PHYSICIAN FELT A POP. ONCE THE ABLATION CATHETER WAS ADVANCED INTO THE LEFT ATRIUM, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA ULTRASOUND. CATHETERS WERE PULLED. PERICARDIOCENTESIS YIELDED 600ML. PATIENT WAS TRANSFERRED TO THE CORONARY CARE UNIT (CCU). PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT OUTCOME WAS IMPROVED. THE PATIENT HAD THE ABLATION PROCEDURE AT SOME POINT (UNSPECIFIED) AFTER THE PERICARDIAL DRAIN WAS PLACED. IT WAS NOTED THAT THE CATHETER WAS NOT THE CAUSE OF THE ADVERSE EVENT. FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE THE PATIENT¿S ANATOMY, SPECIFICALLY A ROTATED HEART AND A FLOPPY SEPTUM. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT WAS THAT IT WAS RELATED TO THE PATIENT¿S ANATOMY AND DIFFICULT SEPTUM. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BAYLIS MEDICAL TRANSSEPTAL NEEDLE AND A ST. JUDE MEDICAL BRK-1 TRANSSEPTAL NEEDLE. SHEATH USED WAS A ST. JUDE MEDICAL SL1. GENERATOR WAS SET AT 25 WATTS. GENERATOR PARAMETERS, OTHER GENERATOR SETTINGS, POWER TITRATION, OVERALL ABLATION TIME AT THE SITE OF INJURY, AND LAST ABLATION CYCLE TIME AT THE SITE OF INJURY WERE NOT REPORTED, AS NO ABLATION WAS PERFORMED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418379 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-04-S 17651261M 10846835009194

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R