BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6371063 · Received March 1, 2017

    Report

    Report Number
    9673241-2017-00172
    Event Type
    Injury
    Date Received
    March 1, 2017
    Date of Event
    January 31, 2017
    Report Date
    January 31, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT RECEIVED ANTICOAGULANT (HEPARIN) DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME TARGET OF GREATER THAN 350 SECONDS. THERE IS NO INFORMATION REGARDING SHAFT PROXIMITY INTERFERENCE (SPI) VALUE. THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER. THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION 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 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. - ST. JUDE MEDICAL BRK TRANSSEPTAL NEEDLE; NON BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL BRK-1 TRANSSEPTAL NEEDLE; NON BIOSENSE WEBSTER, INC. - ST. JUDE AGILIS MEDIUM CURL SHEATH; CARTO 3 SYSTEM, MODEL #: UNKNOWN, SERIAL #: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PULMONARY VEIN ISOLATION ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING ABLATION PHASE, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAM. PERICARDIOCENTESIS YIELDED 140CC. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. 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 HE DID NOT BELIEVE THAT A BIOSENSE WEBSTER, INC. PRODUCT WAS AT FAULT. PHYSICIAN INDICATED THAT A SMALL EPICARDIAL VESSEL MUST HAVE RUPTURED WITH ABLATION AT SOME POINT DURING THE CASE, ALLOWING A SMALL AMOUNT OF BLOOD TO ACCUMULATE IN THE PERICARDIAL SPACE. TRANSSEPTAL PUNCTURE WAS PERFORMED X 2 WITH ST. JUDE MEDICAL BRK AND BRK-1 TRANSSEPTAL NEEDLES. SHEATH IN USE WAS A ST. JUDE AGILIS MEDIUM CURL. GENERATOR SETTINGS INCLUDED POWER CONTROL MODE AT 30-40 WATTS FOR 40 SECONDS ON THE ANTERIOR PORTION OF THE LEFT PULMONARY VEINS, 20 WATTS FOR 15-20 SECONDS ON THE POSTERIOR PORTION OF THE LEFT PULMONARY VEINS, AND TEMPERATURE CUT-OFF OF 42 DEGREES CELSIUS. POWER WAS TITRATED INCREMENTALLY FOR A 10% IMPEDANCE DECREASE, PER THE PHYSICIAN¿S INSTRUCTIONS. IT WAS NOTED THAT THERE WAS NO SPECIFIC TIME OF INJURY IDENTIFIED. NO IMPEDANCE RISES OR TEMPERATURE CUT-OFFS WERE OBSERVED. OVERALL ABLATION TIME AND LAST ABLATION CYCLE TIME AT THE SITE OF INJURY WAS NOT REPORTED, AS THE TIME OF INJURY IS UNKNOWN. IRRIGATED CATHETER FLOW WAS SET ON STANDARD THERMOCOOL SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150586 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S UNK_D-1327-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R