BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 3821892 · Received May 20, 2014

    Report

    Report Number
    9673241-2014-00201
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER A PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN INSPECTED THE THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER TIP AND RECOGNIZED SOME KIND OF FIBROUS ON IT. DURING ABLATION, THERE WAS AN IMPEDANCE RISE WITH A FORCE READING OF 35 G. TOTAL ABLATION TIME WAS 3.5 MINUTES. THERE WERE NO PATIENT CONSEQUENCES. ON MAY 7TH, RECEIVED ADDITIONAL INFORMATION REQUESTED FROM BWI REPRESENTATIVE STATING THAT THE APPROXIMATE SIZE OF IT WAS ONE CUBIC MILLIMETER. THE PHYSICIAN WAS UNSURE WHETHER IT WAS CHAR. THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE RETURNED DEVICE WAS VISUALLY INSPECTED AND THERE WAS A DARK RED MATERIAL FOUND ON TIP OF CATHETER BETWEEN ELECTRODES # 1 AND # 2. PER THE REPORTED EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND FOUND WITHIN SPECIFICATIONS. DUE TO THE DARK RED MATERIAL FOUND, AN IRRIGATION TEST WAS PERFORMED AND CATHETER PASSED. 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 CUSTOMER COMPLAINT IN REGARDS THE FIBRIN (DARK RED MATERIAL) WAS CONFIRMED. HOWEVER, THE CATHETER MET MANUFACTURING SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    SINCE THE LOT # 16047130M WAS PROVIDED, THE DEVICE HISTORY RECORDS 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 REFERENCE # (B)(4).

    Description of Event or Problem · 1

    AFTER A PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN INSPECTED THE THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER TIP AND RECOGNIZED SOME KIND OF FIBROUS ON IT. DURING ABLATION, THERE WAS AN IMPEDANCE RISE WITH A FORCE READING OF 35 G. TOTAL ABLATION TIME WAS 3.5 MINUTES. THERE WERE NO PATIENT CONSEQUENCES. ON (B)(6) RECEIVED ADDITIONAL INFORMATION REQUESTED FROM (B)(6) REPRESENTATIVE STATING THAT THE APPROXIMATE SIZE OF IT WAS ONE CUBIC MILLIMETER. THE PHYSICIAN WAS UNSURE WHETHER IT WAS CHAR. THE GENERATOR SETTING WAS 30 WATTS, 43 DEGREES AND 30 ML/MIN. BASED ON THE AVAILABLE AND CURRENT INFORMATION, IT WAS DETERMINED FOR THIS COMPLAINT TO BE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300347 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-01-S UNK_D-1336-01-S

    Patients

    Seq Age Sex Outcome Treatment
    1