BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 5691754 · Received June 1, 2016

    Report

    Report Number
    9673241-2016-00361
    Event Type
    Injury
    Date Received
    June 1, 2016
    Date of Event
    April 18, 2016
    Report Date
    May 5, 2016
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    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. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 17410937M HAS BEEN REVIEWED AND IT WAS VERIFIED THAT DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. (B)(4), THE DEVICE WAS NOT RETURNED TO BWI.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT IS PART OF A CLINICAL STUDY. IT WAS REPORTED THAT ONE (B)(6) MALE PATIENT WITH MEDICAL HISTORY OF SYMPTOMATIC ATRIAL FIBRILLATION UNDERWENT PULMONARY VEIN ISOLATION PROCEDURE USING SMART TOUCH CATHETER AND SUFFERED PERICARDIAL IRRITATION (WITHOUT EFFUSION) WHICH REQUIRED MEDICATION. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR SENSOR, CARTO 3 FUNCTIONALITY AND THE CATHETER FAILED DURING THE CARTO 3 TEST AS ERROR 105 WAS DISPLAYED. FURTHER EXAMINATION SHOWED THAT THE SENSOR WAS WITHIN SPECIFICATIONS. ACCORDING TO THE CALIBRATION RESULTS AND THE SENSOR READINGS, THE IMPROPER CONDITION WAS ATTRIBUTED TO A POTENTIAL PC BOARD FAILURE. THEN THE CATHETER WAS TESTED FOR DEFLECTION AND THE CATHETER FAILED AND IT WAS NOTICED THAT THE T-BAR SLID DOWN FROM ITS PLACE. THE CATHETER WAS DISSECTED, RESIDUES OF POLYURETHANE APPLICATION WAS FOUND AT THE T-BAR ANCHORED PLACE, DACRON ASSEMBLY WAS IN CORRECT POSITION WHICH INDICATES A PROPER MANUFACTURING ASSEMBLY. THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND GENERATOR COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. THEREFORE, AN IRRIGATION TEST WAS PERFORMED BUT NO WATER LEAKAGE 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 CATHETER FAILED DEFLECTION AND CALIBRATION TESTS; HOWEVER THE ROOT CAUSE OF THE T-BAR DISPLACEMENT CANNOT BE DETERMINED. THERE WAS EVIDENCE OF A PROPER MANUFACTURING ASSEMBLY. AN INTERNAL CORRECTIVE ACTION WAS CREATED TO ADDRESS A POTENTIAL PC BOARD ISSUES/INTERMITTENCY. HOWEVER THE FAILURES ARE NOT RELATED WITH THE PERICARDITIS AND THE ROOT CAUSE OF PERICARDITIS REMAINS UNKNOWN. THE INSTRUCTIONS FOR USE STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE.

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON (B)(6) 2016. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THIS EVENT IS PART OF (B)(4) STUDY. IT WAS REPORTED THAT ONE (B)(6) MALE PATIENT WITH MEDICAL HISTORY OF SYMPTOMATIC ATRIAL FIBRILLATION UNDERWENT PULMONARY VEIN ISOLATION PROCEDURE USING SMART TOUCH CATHETER (CATALOG # D132705, LOT # 17410937M). THE PATIENT HAD PERICARDIAL IRRITATION (WITHOUT EFFUSION) WHICH REQUIRED MEDICATION. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS NOT DEVICE RELATED AND POSSIBLY PROCEDURE RELATED. IT WAS ALSO REPORTED THAT DURING THE SAME PROCEDURE SMART TOUCH CATHETER (CATALOG # D132705, LOT # 17416363M) AND SMART TOUCH CATHETER (CATALOG # D132705, LOT # 17416399M) BOTH USED DURING THIS CASE. BWI TAKES CONSERVATIVE APPROACH TO REPORT THESE EVENTS AND SUBMIT TO FDA SEPARATELY. IT WAS ALSO REPORTED THAT OTHER MDR NOT REPORTABLE PRODUCT ISSUES OCCURRED DURING THE SAME PROCEDURE. SMART TOUCH CATHETER (CATALOG # D132705, LOT # 17416399M) HAD SIGNAL INTERFERENCE (NOISE) ON IC ONLY ON BOTH CARTO AND RECORDING SYSTEM. THE PHYSICIAN HAD AT LEAST ONE ECG SIGNAL AVAILABLE TO MONITOR PATIENT HEART RHYTHM. IT WAS ALSO REPORTED THAT DURING THE SAME PROCEDURE SMART TOUCH CATHETER (CATALOG # D132705, LOT # 17416363M) AND SMART TOUCH CATHETER (CATALOG # D132705, LOT # 17410937M) BOTH HAD ERROR 19 AND 8 (PIU E661 CARD BIT ERROR). THE CARTO SYSTEM WAS BLOCKED WHEN TAKING THE BACK-UP AND WAS MANUALLY SHUT DOWN POST USE. THE PACING LEADS WERE CONNECTED TO CARTO 3 PIU PRIMARY PACING PORT, AND CARTO WAS FUNCTION WELL (DID NOT ALLOW PACING AND ABLATING AT THE SAME TIME). MICROPACE PACING STIMULATOR WAS BEING USED DURING THE PROCEDURE. IT WAS A PLANNED PACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347833 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S 17410937M

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R