BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 6207900 · Received December 27, 2016

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    Report

    Report Number
    9673241-2016-00900
    Event Type
    Injury
    Date Received
    December 27, 2016
    Date of Event
    November 30, 2016
    Report Date
    November 30, 2016
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED ON THE EVENT ON JANUARY 4, 2017 STATING THAT THE IMPELLA WAS USED BEFORE THE EVENT TO MAP THE VENTRICULAR TACHYCARDIA AND BECAUSE THE PATIENT HAD A LOW EJECTION FRACTION. (B)(4).

    Additional Manufacturer Narrative · 1

    TIME AT THE SITE OF INJURY. IRRIGATED CATHETER FLOW WAS SET AT 8ML/MIN. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME MAINTAINED AT 300 SECONDS DURING ENDOCARDIAL ABLATION AND LOWER DURING EPICARDIAL ABLATION. THERE IS NO INFORMATION REGARDING SPI VALUE. THERMOCOOL SMARTTOUCH SF CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER. THERMOCOOL SMARTTOUCH SF CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE, POST-CONNECTION TO THE CARTO 3 PATIENT INTERFACE UNIT. CARTO 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. THERE WERE NO ERROR MESSAGES 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. 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 17475289L HAS BEEN REVIEWED AND IT WAS VERIFIED THAT DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN EPICARDIAL ABLATION PROCEDURE FOR VENTRICULAR TACHYCARDIA WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND SUFFERED A CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS) AND HEART FAILURE (REQUIRING A SURGICAL INTERVENTION: IMPELLA VENTRICULAR ASSIST DEVICE). AT THE END OF THE PROCEDURE, WHEN THE CATHETER WAS BEING REMOVED, BLOOD WAS OBSERVED IN THE SHEATH. BLOOD PRESSURE BECAME SLIGHTLY REDUCED. PERICARDIOCENTESIS YIELDED AN UNKNOWN AMOUNT OF FLUID. PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME OF COMPLAINT REPORT. PATIENT TRANSFERRED TO THE OPERATING ROOM FOR AN IMPELLA VENTRICULAR ASSIST DEVICE (VAD). PATIENT REQUIRED EXTENDED HOSPITALIZATION DUE TO HIS REDUCED RIGHT VENTRICULAR FUNCTION AND FOR RECOVERY FROM THE IMPELLA PLACEMENT. PATIENT OUTCOME WAS NOTED TO BE WORSENED, AS THE PATIENT REMAINS HOSPITALIZED. PATIENT FACTORS THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE THAT THE PATIENT HAD A LOW EJECTION FRACTION. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE IS THAT IT WAS RELATED TO PROCEDURE, AS EPICARDIAL ABLATION INVOLVES RISK AND RELATED TO PATIENT CONDITION, AS THE PATIENT¿S CARDIAC HEALTH WAS COMPROMISED. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BROCKENBROUGH EXTRA SHARP (BRK-XS) TRANSSEPTAL NEEDLE. THERE IS NO SHEATH INFORMATION. GENERATOR PARAMETERS AT THE TIME OF INJURY INCLUDED: POWER CONTROL MODE AT 30 WATTS (NOT TITRATED) WITH DEFAULT TEMPERATURE CUT-OFF. OVERALL ABLATION TIME WAS APPROXIMATELY 20 MINUTES. THERE IS NO INFORMATION REGARDING LAST ABLATION CYCLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855689 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-05-S 17475289L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R