BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 7042321 · Received November 17, 2017

    Report

    Report Number
    2029046-2017-01158
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    October 30, 2017
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009774
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 17698360L HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. CONCOMITANT PRODUCTS: PENTARAY NAVIGATIONAL ECO CATHETER, US CATALOG #: D128211, LOT #: 17566590L. WEBSTER CATHETER, US CATALOG #: 1085122RT, LOT #: 17699810L. CARTO 3 SYSTEM. NON BIOSENSE WEBSTER INC. - ST JUDE MEDICAL SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER- (407451 / LOT # 11764). NON BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL AGILIS STEERABLE INTRODUCER (408310/ LOT #:5841268). NON BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL BRK XS SERIES TRANSSEPTAL NEEDLE (G407208/LOT #:6092230). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATYPICAL LEFT ATRIAL FLUTTER WITH A THERMOCOOL SMARTTOUCH UNIDIRECTIONAL SF CATHETER UNDER LOCAL ANESTHESIA AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING ABLATION OF THE MITRAL ISTHMUS, A PERICARDIAL EFFUSION WAS DETECTED. PERICARDIOCENTESIS YIELDED 430 ML. REMAINDER OF PROCEDURE WAS ABORTED. PATIENT CONDITION IMPROVED POST-PERICARDIOCENTESIS. PATIENT REQUIRED SEVERAL DAYS OF EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT FOR OBSERVATION. 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 IS PROCEDURE-RELATED. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK XS SERIES TRANSSEPTAL NEEDLE. SHEATHS INCLUDED A ST. JUDE MEDICAL SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER AND A ST. JUDE MEDICAL AGILIS STEERABLE INTRODUCER. GENERATOR PARAMETERS AT THE TIME OF INJURY INCLUDED POWER CONTROL MODE AT 40 WATTS WITH TEMPERATURE CUT-OFF OF 50 DEGREES CELSIUS. GENERATOR SETTINGS AT THE TIME OF INJURY INCLUDED POWER AT 40 WATTS (NOT TITRATED), IMPEDANCE OF 130-140 OHMS, AND CONTACT FORCE OF 3-40 GRAMS. THERE IS NO INFORMATION REGARDING OVERALL ABLATION TIME OR LAST ABLATION CYCLE TIME AT THE SITE OF INJURY. IRRIGATED CATHETER FLOW WAS SET AT 8 ML/MIN DURING LOW FLOW AND 17 ML/MIN DURING HIGH FLOW. THERE IS NO INFORMATION REGARDING ANTICOAGULATION DURING THE PROCEDURE. FORCE VISUALIZATION FEATURES USED INCLUDED GRAPH, DASHBOARD, VECTOR, AND VISITAG. PARAMETERS FOR STABILITY INCLUDED A RANGE OF 2 MM AND TIME OF 3 SECONDS. ADDITIONAL FILTER USED WITH THE VISITAG INCLUDED FORCE-OVER-TIME (FOT) OF 25 % AND 3 GRAMS. COLOR OPTIONS USED INCLUDED TOTAL TIME. THERE IS NO INFORMATION REGARDING SHAFT PROXIMITY INTERFERENCE VALUE. THERMOCOOL SMARTTOUCH UNIDIRECTIONAL SF CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER. THERMOCOOL SMARTTOUCH 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820005 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134701 17698360L 10846835009774

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R