BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 6207844 · Received December 27, 2016

    Report

    Report Number
    9673241-2016-00894
    Event Type
    Injury
    Date Received
    December 27, 2016
    Date of Event
    November 28, 2016
    Report Date
    November 29, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION CONTINUATION: STARTED TO DETERIORATE PRIOR TO ABLATION. IRRIGATED CATHETER FLOW WAS SET ON SMARTTOUCH SF D-F SETTINGS. THERE IS NO INFORMATION REGARDING ANTICOAGULATION DURING THE PROCEDURE. THERE IS NO INFORMATION REGARDING SPI VALUE. SMARTTOUCH CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER. SMARTTOUCH WAS ZEROED AFTER THE INITIAL WARM-UP PHASE, POST-CONNECTION TO THE CARTO 3 PIU. THERE IS NO INFORMATION REGARDING THE CARTO 3 SYSTEM INDICATING TO RE-ZERO THE CATHETER. THERE WERE NO ERRORS REPORTED 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. THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR VENTRICULAR TACHYCARDIA/PREMATURE VENTRICULAR CONTRACTIONS (PVCS) WITH A THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS WITH PERICARDIAL DRAIN. DURING ABLATION PHASE, AFTER ONE 20 SECOND BURN, A TAMPONADE WAS OBSERVED. PERICARDIOCENTESIS YIELDED AN UNKNOWN AMOUNT OF FLUID. REMAINDER OF PROCEDURE WAS ABORTED. PATIENT WAS TRANSFERRED TO THE CORONARY CARE UNIT WITH PERICARDIAL DRAIN IN PLACE. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THIS ADVERSE EVENT. EVENT WAS ASSESSED TO BE LIFE-THREATENING. THERE IS NO FURTHER INFORMATION REGARDING PATIENT OUTCOME. THERE WERE NO PATIENT FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. IT IS UNCLEAR AT THIS TIME AS TO THE PHYSICIAN¿S OPINION REGARDING CAUSALITY (AWAITING CLARIFICATION). TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. THERE IS NO SHEATH INFORMATION. GENERATOR WAS IN POWER CONTROL MODE (FACTORY SETTINGS). TEMPERATURE, IMPEDANCE, AND POWER WERE ON STANDARD STSF SETTINGS. DURING MAPPING, THERE WERE HIGH IMPEDANCE READINGS OF MORE THAN 400 OHMS. PHYSICIAN WAS NOTIFIED AT THE TIME OF THE OCCURRENCE. SINCE THIS IMPEDANCE ISSUE WAS DURING MAPPING, IT WAS ASSESSED AS NOT REPORTABLE. DURING ABLATION, IMPEDANCE WAS 100-180 OHMS AND NO CUT-OFF VALUES WERE EXCEEDED. SINCE IT DID NOT EXCEED THE CUT-OFF VALUE, THIS IMPEDANCE ISSUE WAS ASSESSED AS NOT REPORTABLE. OVERALL ABLATION TIME WAS 20 SECONDS. IT WAS NOTED THAT THERE WAS ONLY ONE ABLATION AND THAT THE PATIENT¿S CONDITION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855427 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 Hospitalization| L| R