BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4171772 · Received October 15, 2014

    Report

    Report Number
    2029046-2014-00375
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. THE SYSTEM DID STOP ABLATION WHEN THE IMPEDANCE CUTOFF VALUE OF 200 OHMS WAS REACHED. (B)(4) IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SMART TOUCH UNIDIRECTIONAL CATHETER, AND A CHAR ISSUE OCCURRED. THE CATHETER TIP HAD CHAR ON IT WHEN IT WAS REMOVED FROM THE PATIENT. THE CATHETER FLUSHED NORMALLY AT THE BEGINNING OF THE PROCEDURE AND THE FLUSH WAS NORMAL DURING THE PROCEDURE. SETTINGS DURING THE EVENT INCLUDE: POWER CONTROL MODE / POWER SETTINGS WERE BETWEEN 30-40 WATTS / IRRIGATION FLOW SETTING 30ML/MIN. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED ON THE EVENT. HIGH IMPEDANCE WAS NOTED DURING THE ENTIRE CASE. THE PHYSICIAN DID NOT NOTICE ANY ABNORMAL CATHETER IRRIGATION BEFORE OR AFTER THE EVENT. THE ABLATION WAS NOT DELIVERED MORE THAN 15 SECONDS AT ONE SPOT. THE APPROXIMATE SIZE OF THE CHAR WAS <1MM. THE PHYSICIAN CONSIDERED THAT THE CHAR WAS EXCESSIVE. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND THERE WAS CHAR ON PROXIMAL SIDE OF TIP DOME MEASURING ABOUT 2.4 MM. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. IN ADDITION, AN IRRIGATION TEST WAS PERFORMED AND CATHETER PASSED, NO OCCLUSION WAS OBSERVED. 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 HAS BEEN VERIFIED. HOWEVER, THE CATHETER MET THE MANUFACTURING SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SMART TOUCH UNIDIRECTIONAL CATHETER, AND A CHAR ISSUE OCCURRED. THE CATHETER TIP HAD CHAR ON IT WHEN IT WAS REMOVED FROM THE PATIENT. THE CATHETER FLUSHED NORMALLY AT THE BEGINNING OF THE PROCEDURE AND THE FLUSH WAS NORMAL DURING THE PROCEDURE. SETTINGS DURING THE EVENT INCLUDE: POWER CONTROL MODE / POWER SETTINGS WERE BETWEEN 30-40 WATTS / IRRIGATION FLOW SETTING 30ML/MIN. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED ON THE EVENT. HIGH IMPEDANCE WAS NOTED DURING THE ENTIRE CASE. THE PHYSICIAN DID NOT NOTICE ANY ABNORMAL CATHETER IRRIGATION BEFORE OR AFTER THE EVENT. THE ABLATION WAS NOT DELIVERED MORE THAN 15 SECONDS AT ONE SPOT. THE APPROXIMATE SIZE OF THE CHAR WAS <1MM. THE PHYSICIAN CONSIDERED THAT THE CHAR WAS EXCESSIVE. THE SIZE OF THE CHAR MEASURING <1MM WAS NOT CONSIDERED A REPORTABLE EVENT. UPON VISUAL INSPECTION OF THE RETURNED COMPLAINT CATHETER ON OCTOBER 10, 2014, THE BWI FAILURE ANALYSIS LAB NOTED CHAR ON THE PROXIMAL SIDE OF TIP DOME WHICH MEASURED ABOUT 2.4 MM. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF THE AMOUNT OF CHAR NOTED OF 2.4 MM ON (B)(4) 2014 AND HAVE REASSESSED THE EVENT AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654719 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1336-01-S 17005935M

    Patients

    Seq Age Sex Outcome Treatment
    1