BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4707578 · Received April 20, 2015

    Report

    Report Number
    9673241-2015-00211
    Event Type
    Malfunction
    Date Received
    April 20, 2015
    Date of Event
    January 20, 2015
    Report Date
    January 23, 2015
    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
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. CONCOMITANT PRODUCTS: UNK (B)(4). THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    SINCE THE TIME OF THE INITIAL MDR SUBMISSION, ADDITIONAL INFORMATION WAS RECEIVED THAT THE CATHETER WAS NOT BROKEN DURING THE PROCEDURE, WHICH MAKES THIS A NON-MDR REPORTABLE COMPLAINT. (B)(4) IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND NON-MDR REPORTABLE MAPPING AND CATHETER VISUALIZATION ISSUES OCCURRED. THE BWI FAILURE ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR ANALYSIS AND DISCOVERED THAT THE SHAFT OF THE COMPLAINT DEVICE WAS BROKEN LEAVING INTERNAL PARTS EXPOSED. THIS COMPLAINT WAS ORIGINALLY REPORTED TO DUE TO THE PHYSICAL DAMAGE OF THE CATHETER. HOWEVER, SINCE THE TIME OF THE INITIAL MDR SUBMISSION, ADDITIONAL INFORMATION WAS RECEIVED THAT THE CATHETER WAS NOT BROKEN DURING THE PROCEDURE, WHICH MAKES THIS A NON-MDR REPORTABLE COMPLAINT. UPON RECEIPT OF THE COMPLAINT DEVICE BY BWI, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND THAT THE PEEK HOUSING WAS BENT NEXT TO THE POLYURETHANE (PU) MARGIN ON THE PROXIMAL SIDE OF RING # 3, CAUSING THE TIP SECTION TO BE SLIGHTLY BENT. THE SHAFT WAS BENT AND BROKEN OPEN WITH INTERNAL PARTS EXPOSED. FURTHER INFORMATION RECEIVED INDICATES THAT THE DAMAGES OCCURRED AFTER THE PROCEDURE DURING DECONTAMINATION IN THE HOSPITAL. THERE WERE NO DAMAGES ON THE PRODUCT WHEN IT WAS USED ON THE PATIENT DURING THE SURGERY. PER THE EVENT REPORTED, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE, AND STOCKERT COMPATIBILITY. THE DEVICE FAILED ON ELECTRODE #4 AND THERMOCOUPLE. FURTHER EXAMINATION REVEALED THAT THE LEAD WIRE #4 AND THERMOCOUPLE HAD AN INTERMITTENCE ISSUE CAUSING AN IMPROPER SIGNAL CONDITION. OFFPLANE AND PRECURVE TESTS FAILED DUE TO THE SHAFT CONDITION. THE FUNCTIONALITY OF THE SENSOR CATHETER WAS ALSO TESTED ON THE CARTO SYSTEM. THE CATHETER FAILED DURING THE CARTO TESTS, ERROR 106 WAS DISPLAYED. THE CATHETER WAS THEN DISSECTED AND IT WAS DETERMINED THAT THE ROOT CAUSE WAS AN INTERNAL FAILURE OF THE SENSOR. THE ORIGINAL CUSTOMER COMPLAINT HAS BEEN VERIFIED. HOWEVER, THE CATHETER'S SHAFT WAS NOT BROKEN DURING THE PROCEDURE, SO THIS IS A NON-MDR REPORTABLE COMPLAINT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER AND NON-MDR REPORTABLE MAPPING AND CATHETER VISUALIZATION ISSUES OCCURRED. THE BWI FAILURE ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR ANALYSIS. ANALYSIS REVEALED THAT THE SHAFT OF THE COMPLAINT DEVICE WAS BROKEN LEAVING INTERNAL PARTS EXPOSED. THIS IS A REPORTABLE DEVICE LAB FINDING, AS THE BREAK IS WITHIN A LENGTH OF CATHETER THAT COULD HAVE EXPOSED THE PATIENT TO RISK. PER THE EVENT DESCRIPTION, THERE WAS NO CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A SIMILAR LIKE DEVICE. THE AWARENESS DATE WAS UPDATED FOR THIS COMPLAINT TO 3/31/2015, THE DATE SAID ISSUE WAS DISCOVERED IN THE BWI LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261747 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S 17098233M

    Patients

    Seq Age Sex Outcome Treatment
    1