BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 6673677 · Received June 28, 2017

    Report

    Report Number
    9673241-2017-00528
    Event Type
    Injury
    Date Received
    June 28, 2017
    Date of Event
    June 5, 2017
    Report Date
    June 5, 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 Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 7/10/2017. 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

    EVENT DESCRIPTION CONTINUATION: SECONDS. THERE IS NO INFORMATION REGARDING SHAFT PROXIMITY INTERFERENCE VALUE. THERMOCOOL SMARTTOUCH BIDIRECTIONAL SF CATHETER WAS IN CLOSE PROXIMITY TO THE LASSO CATHETER. THERMOCOOL SMARTTOUCH BIDIRECTIONAL SF 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 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 NUMBER 17667164L HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. CONCOMITANT PRODUCTS: LASSO CATHETER: MODEL #: UNKNOWN, LOT #: UNKNOWN. NON BIOSENSE WEBSTER, INC. - COOK MEDICAL 71CM TRANSSEPTAL NEEDLE. NON BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL SL0 8.5 FRENCH SHEATH. CARTO 3 SYSTEM: MODEL #: UNKNOWN, SERIAL #: UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BIDIRECTIONAL SF CATHETER. DURING THE ABLATION PHASE, TOWARD THE END OF THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE WITH A DECREASE IN SYSTOLIC BLOOD PRESSURE FROM 110 MMHG TO 90 MMHG. A CARDIACT TAMPONADE WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAM (ICE). PERICARDIOCENTESIS YIELDED AN UNSPECIFIED AMOUNT OF FLUID. BLOOD PRESSURE STABILIZED. PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR OBSERVATION. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT OUTCOME WAS IMPROVED. 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 (IFU) 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 (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BIDIRECTIONAL SF CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING ABLATION PHASE, TOWARD THE END OF THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE WITH A DECREASE IN SYSTOLIC BLOOD PRESSURE FROM 110MMHG TO 90MMHG. TAMPONADE WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAM (ICE). PERICARDIOCENTESIS YIELDED AN UNSPECIFIED AMOUNT OF FLUID. BLOOD PRESSURE STABILIZED. PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR OBSERVATION. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT OUTCOME WAS IMPROVED. CARDIOVASCULAR MEDICAL HISTORY INCLUDES A PERMANENT PACEMAKER AND A BASELINE EFFUSION. FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE A BASELINE EFFUSION. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO PATIENT CONDITION. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A COOK MEDICAL 71CM TRANSSEPTAL NEEDLE. ST. JUDE MEDICAL SL0 8.5 FRENCH SHEATH WAS USED. GENERATOR WAS SET ON POWER CONTROL MODE. THERE IS NO INFORMATION REGARDING GENERATOR SETTINGS, POWER TITRATION, OVERALL ABLATION TIME AT THE SIGHT OF INJURY, OR LAST ABLATION CYCLE TIME AT THE SITE OF INJURY. IRRIGATED CATHETER FLOW WAS SET AT 15ML/MIN. PATIENT RECEIVED ANTICOAGULANT (HEPARIN) DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME MAINTAINED BETWEEN 300-350... (EVENT DESCRIPTION TO BE CONTINUED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453729 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-04-S 17667164L 10846835010176

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R