BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 6233981 · Received January 9, 2017

    Report

    Report Number
    9673241-2017-00041
    Event Type
    Injury
    Date Received
    January 9, 2017
    Date of Event
    December 16, 2016
    Report Date
    December 19, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION CONTINUATION: INJURY WAS 20-30 SECONDS. IRRIGATED CATHETER FLOW WAS SET ON 8 ML/MIN. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIMES MAINTAINED BETWEEN 300-350 SECONDS. THERE IS NO INFORMATION REGARDING SHAFT PROXIMITY INTERFERENCE (SPI) VALUE. THERMOCOOL SMARTTOUCH BI-DIRECTIONAL SF CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER. THERMOCOOL SMARTTOUCH BI-DIRECTIONAL SF CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE, POST-CONNECTION TO THE CARTO 3 PATIENT INTERFACE UNIT (PIU). CARTO 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. ERRORS REPORTED BY BIOSENSE WEBSTER, INC. EQUIPMENT INCLUDED THE IMPEDANCE EXCEEDING THE CUTOFF VALUE OF 250 OHMS. 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. THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. 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 PRODUCT: NON-BIOSENSE WEBSTER, INC. - BOSTON SCIENTIFIC TRANSSEPTAL NEEDLE. NON-BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL SL1 8.5 FRENCH SHEATH. CARTO 3 SYSTEM, MODEL #: M-4800-01, SERIAL #: (B)(4). SMARTABLATE PUMP, MODEL #: M-4900-08, SERIAL #: (B)(4). LASSO NAVIGATIONAL VARIABLE ECO CATHETER MODEL #: D-1343-01-S. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BI-DIRECTIONAL SF CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. DURING ABLATION, AN IMPEDANCE JUMP WAS NOTED IN A PREVIOUSLY ABLATED SEGMENT. PATIENT BECAME HYPOTENSIVE AND WAS NOT RESPONDING TO PHARMACOLOGIC SUPPORT. TAMPONADE WAS CONFIRMED VIA ECHOCARDIOGRAM. PERICARDIOCENTESIS YIELDED 180 CC. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT WAS DISCHARGED THE FOLLOWING MORNING. PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. FACTORS THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE THE PATIENT¿S LEFT ATRIAL ANATOMY AND EXTENSIVE ABLATION IN A SPECIFIC AREA. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO THE PATIENT¿S ANATOMY IN THE AREA OF SUSPECTED INJURY. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BOSTON SCIENTIFIC TRANSSEPTAL NEEDLE. SHEATH USED WAS A ST. JUDE MEDICAL SL1 8.5 FRENCH. GENERATOR PARAMETERS INCLUDED POWER CONTROL MODE WITH TEMPERATURE CUT-OFF OF 40 DEGREES CELSIUS. POWER CUT-OFF WAS NOT REPORTED. GENERATOR SETTINGS AT THE TIME OF INJURY INCLUDED POWER AT 30 WATTS (NOT TITRATED) AND TEMPERATURE OF 32 DEGREES CELSIUS. IT WAS NOTED THAT DURING AN EARLIER ABLATION, THE IMPEDANCE CUT-OFF VALUE OF 250 OHMS WAS EXCEEDED. THERE IS NO INFORMATION REGARDING OVERALL ABLATION TIME AT THE SITE OF INJURY. LAST ABLATION CYCLE TIME AT THE SITE OF

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16459 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-05-S UNKNOWN_D-1348-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening| R