BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 5486881 · Received March 8, 2016

    Report

    Report Number
    9673241-2016-00169
    Event Type
    Injury
    Date Received
    March 8, 2016
    Date of Event
    February 16, 2016
    Report Date
    February 16, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. 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. THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER APPROVED UNDER P030031/S053. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER AND SUFFERED A PERICARDIAL EFFUSION WHICH REQUIRED HOSPITALIZATION. AFTER NORMAL PULMONARY VEIN ISOLATION, THE PHYSICIAN RECOGNIZED A PERICARDIAL EFFUSION BY ULTRASOUND DIAGNOSTICS. THE PATIENT WAS STABLE AT THE TIME THIS COMPLAINT WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH AN UNKNOWN NEEDLE. ANTICOAGULATION WAS PROVIDED TO THE PATIENT AND MAINTAINED AT 300-350S AND GREATER THAN OR EQUAL TO 350S. BLOOD PRESSURE AND HEART RATE WERE MONITORED AND BOTH WITHIN NORMAL RESULTS DURING THE PROCEDURE. THE SITE OF INJURY IS UNKNOWN AS IT WAS NOT KNOWN IF THE INJURY HAPPENED DURING ABLATION. PRESUMABLY THE INJURY HAPPENED AFTER ABLATION AND DURING SHEATH OR CATHETER MOVEMENT. NO MEDICAL OR SURGICAL INTERVENTION WAS PROVIDED, HOWEVER THE PATIENT WAS HOSPITALIZED FOR TWO DAYS DUE TO THE EVENT. THE PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. SETTINGS DURING THE EVENT INCLUDE: POWER CONTROL MODE / POWER SETTING 30 WATTS / IRRIGATION FLOW SETTING 8ML/MIN AS STANDARD FOR 30W ABLATION. THERE WERE NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS IS A NORMAL PROCEDURE COMPLICATION, WHICH COULD BE RELATED TO SHEATH, CATHETER OR TECHNIQUE. THERE WAS NO CATHETER MALFUNCTION, OPINION TO THE CATHETER FEATURES WAS POSITIVE, NO PROBLEMS WITH THE CATHETER WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143645 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-05-S 17249827L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization