BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6055706 · Received October 25, 2016

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    Report

    Report Number
    9673241-2016-00737
    Event Type
    Injury
    Date Received
    October 25, 2016
    Date of Event
    October 4, 2016
    Report Date
    October 4, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR IDIOPATHIC VENTRICULAR TACHYCARDIA WITH A THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. AFTER THE CASE WAS COMPLETED AND THE CATHETERS AND SHEATH WERE REMOVED, THE PATIENT BECAME DIAPHORETIC AND HYPOTENSIVE. TAMPONADE WAS CONFIRMED VIA ECHOCARDIOGRAM. PERICARDIOCENTESIS YIELDED AN UNKNOWN AMOUNT OF FLUID. PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME OF COMPLAINT REPORT. PATIENT REQUIRED AN OVERNIGHT HOSPITAL STAY FOR OBSERVATION. PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. MEDICAL HISTORY INCLUDES: CONGESTIVE HEART FAILURE, VENTRICULAR BIGEMINY, ESSENTIAL HYPERTENSION, AND LOWER EXTREMITY EDEMA. LABS INCLUDE: CREATININE 1.49, PLATELETS 254, POTASSIUM 4, HEMOGLOBIN 15.3, HEMATOCRIT 45.2, AND GLUCOSE 123. FACTORS THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE A DIFFICULT TRANSSEPTAL PUNCTURE. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED, AS IT INVOLVED TRANSSEPTAL PUNCTURE. IT WAS NOTED THAT THE INJURY MAY HAVE OCCURRED AFTER A DIFFICULT TRANSSEPTAL PUNCTURE OR PRIOR TO THE CATHETER ENTERING THE VENTRICLE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK 98CM NEEDLE. SHEATH USED WAS A MOBICATH 8.5 FRENCH. GENERATOR PARAMETERS AT THE TIME OF INJURY INCLUDED: POWER CONTROL MODE AT 40 WATTS WITH TEMPERATURE WARNING AT 40°C AND CUT-OFF AT 42°C. IT WAS REPORTED THAT NOTHING UNUSUAL WAS NOTED DURING ABLATION. TOTAL RADIOFREQUENCY TIME WAS 9 MINUTES AND 22 SECONDS. THERE IS NO INFORMATION REGARDING LAST ABLATION CYCLE TIME AT THE SITE OF INJURY. IRRIGATED CATHETER FLOW SETTING WAS 30ML/MIN WHEN ABLATING AT 40 WATTS. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIMES MAINTAINED BETWEEN 300-350 SECONDS. THERE WERE NO ERROR MESSAGES ON ANY BWI EQUIPMENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704212 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S 17553106M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R