BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 6517536 · Received April 24, 2017

    Report

    Report Number
    9673241-2017-00310
    Event Type
    Injury
    Date Received
    April 24, 2017
    Date of Event
    April 3, 2017
    Report Date
    April 3, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION CONTINUATION: THERMOCOOL SMARTTOUCH BI-DIRECTIONAL 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 ERROR MESSAGES OBSERVED ON ANY BWI 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 17642770L HAS BEEN REVIEWED AND IT WAS VERIFIED THAT DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. CONCOMITANT MEDICAL PRODUCTS: CARTO 3 SYSTEM, MODEL #: M-4800-01, SERIAL #: (B)(4); SMARTABLATE PUMP, MODEL #: M-4900-08, SERIAL #: (B)(4); SMARTABLATE GENERATOR, MODEL #: M-4900-07, SERIAL #: (B)(4); EZ STEER CORONARY SINUS CATHETER, MODEL #: D-1263-05-S, LOT #: 17638062M; LASSO NAVIGATIONAL VARIABLE ECO CATHETER, MODEL #: D-1343-01-S, LOT #: 17603378L; SOUNDSTAR ECO CATHETER, MODEL #: M-5723-15, LOT #: E5028376; NON-BIOSENSE WEBSTER, INC. - (B)(4) RF TRANSSEPTAL NEEDLE; NON-BIOSENSE WEBSTER, INC. - (B)(4) AGILIS SHEATH. (B)(4).

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 5/11/17. 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. DURING A PEER REVIEW, WE FOUND A CORRECTION ON THE MANUFACTURED DATE, EXPIRATION DATE, AND THE UDI #. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A FEMALE PATIENT, OF AN UNSPECIFIED AGE, UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BI-DIRECTIONAL SF CATHETER. DURING THE ABLATION PHASE, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAM. PERICARDIOCENTESIS YIELDED 200 ML. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT OUTCOME IS 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, HOWEVER. 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 FEMALE PATIENT, OF AN UNSPECIFIED AGE, UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BI-DIRECTIONAL SF CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING ABLATION PHASE, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAM. PERICARDIOCENTESIS YIELDED 200ML. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT DID NOT REQUIRE 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 IT WAS RELATED TO PATIENT CONDITION. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BAYLIS MEDICAL RF TRANSSEPTAL NEEDLE. SHEATH IN USE WAS A ST. JUDE MEDICAL AGILIS. GENERATOR PARAMETERS AT THE TIME OF INJURY INCLUDED POWER CONTROL MODE AT 30 WATTS WITH TEMPERATURE CUT-OFF OF 40 DEGREES CELSIUS. GENERATOR SETTINGS AT THE TIME OF INJURY INCLUDED TEMPERATURE IN THE LOW-MID 20S, IMPEDANCE BETWEEN 100-120 OHMS, AND POWER AT 25-30 WATTS. POWER WAS NOT TITRATED. OVERALL ABLATION TIME AT THE SITE OF INJURY WAS 37 MINUTES AND 19 SECONDS. LAST ABLATION CYCLE TIME AT THE SITE OF INJURY WAS 28 SECONDS. IRRIGATED CATHETER FLOW WAS SET AT 8ML/MIN. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME MAINTAINED BETWEEN 300-350 SECONDS. THERE IS NO INFORMATION REGARDING SHAFT PROXIMITY INTERFERENCE VALUE. THERMOCOOL SMARTTOUCH BI-DIRECTIONAL SF CATHETER WAS IN CLOSE PROXIMITY TO THE LASSO NAVIGATIONAL VARIABLE ECO CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299049 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-05-S 17642770L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R