BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER

    MDR report key: 6458281 · Received April 4, 2017

    Report

    Report Number
    2029046-2017-00093
    Event Type
    Injury
    Date Received
    April 4, 2017
    Date of Event
    March 14, 2017
    Report Date
    March 14, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION CONTINUATION: SMART TOUCH UNIDIRECTIONAL SF CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER. SMART TOUCH UNIDIRECTIONAL SF CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE POST CATHETER CONNECTION TO THE CARTO® 3 PATIENT INTERFACE UNIT. CARTO® 3 SYSTEM DID 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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CAN NOT BE PROVIDED. CONCOMITANT PRODUCTS: NON BIOSENSE WEBSTER, INC - STRYKER DIAGNOSTIC CATHETERS (3 QUADRIPOLARS AND 1 DECAPOLAR); 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). SOUNDSTAR ECO CATHETER; MODEL #: UNKNOWN; SERIAL #: UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR SUPRAVENTRICULAR TACHYCARDIA (SVT) WITH A SMART TOUCH UNIDIRECTIONAL SF CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS/PERICARDIAL WINDOW AND SURGICAL INTERVENTION. DURING ABLATION PHASE, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA ULTRASOUND. PERICARDIOCENTESIS YIELDED 400 CC. PERICARDIAL WINDOW WAS PERFORMED AND THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR THORACOTOMY TO PATCH THE PERFORATION. THERE IS NO INFORMATION REGARDING PATIENT CONDITION AFTER THE ADVERSE EVENT. ADVERSE EVENT WAS CONSIDERED TO BE LIFE-THREATENING. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT OUTCOME WAS 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 THE PROCEDURE. 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 THE SCREENING TEST AND THE 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.

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 4/21/2017. 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

    ORIGINALLY THE LOT # REPORTED WAS ¿UNKNOWN¿. HOWEVER, THE PRODUCT WAS RECEIVED FOR ANALYSIS. DURING THE ASSESSMENTS ON MAY 5, 2017, THE LOT NUMBER WAS PROVIDED OF 17608026L. THE MANUFACTURED DATE AND EXPIRATION DATE HAVE BEEN PROVIDED. THEREFORE, EXPIRATION DATE, MANUFACTURED DATE AND UDI # HAVE BEEN POPULATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR SUPRAVENTRICULAR TACHYCARDIA (SVT) WITH A SMART TOUCH UNIDIRECTIONAL SF CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS/PERICARDIAL WINDOW AND SURGICAL INTERVENTION. DURING ABLATION PHASE, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA ULTRASOUND. PERICARDIOCENTESIS YIELDED 400CC. PERICARDIAL WINDOW WAS PERFORMED AND THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR THORACOTOMY TO PATCH THE PERFORATION. THERE IS NO INFORMATION REGARDING PATIENT CONDITION AFTER THE ADVERSE EVENT. ADVERSE EVENT WAS CONSIDERED TO BE LIFE-THREATENING. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT OUTCOME WAS 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 THE PROCEDURE. THERE IS NO INFORMATION REGARDING TRANSSEPTAL PUNCTURE OR SHEATH. THERE IS NO INFORMATION REGARDING GENERATOR PARAMETERS OR SETTINGS AT THE TIME OF INJURY. POWER WAS NOT TITRATED. THERE IS NO INFORMATION REGARDING OVERALL ABLATION TIME OR LAST ABLATION CYCLE TIME AT THE SITE OF INJURY. IT WAS NOTED THAT THERE WERE SEVERAL ABLATION LESIONS IN THE LEFT ATRIUM, EACH LASTING 20 SECONDS OR LESS. IRRIGATED CATHETER FLOW WAS SET AT 8ML/MIN. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME OF APPROXIMATELY 250 SECONDS. THERE IS NO INFORMATION REGARDING SHAFT PROXIMITY INTERFERENCE (SPI) VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237917 THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (IRWINDALE) D-1347-02-S UNKNOWN-D1347-02-S

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R