BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4415266 · Received January 13, 2015

    Report

    Report Number
    9673241-2015-00023
    Event Type
    Malfunction
    Date Received
    January 13, 2015
    Date of Event
    October 16, 2014
    Report Date
    October 16, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER, EXPERIENCED FORCE ISSUES AND THEY WERE UNABLE TO ABLATE, HOWEVER, THIS ARE NOT REPORTABLE EVENTS. THIS EVENT IS BEING REPORTED BECAUSE THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND FOUND THAT PEEK HOUSING AND TIP LUMEN TRANSITION HAS A SMALL BUMP WITH METAL EXPOSED AND PU IS DAMAGED. THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. UPON RECEIVING, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND THAT THE PEEK HOUSING AND TIP LUMEN TRANSITION HAS SMALL BUMP WITH METAL EXPOSED AND PU IS DAMAGED. THIS CONDITION WAS NOT NOTICED BY THE CUSTOMER PRIOR TO SHIPPING. AN X-RAY OF THE CATHETER PULLER WIRE WAS TAKEN AND IT WAS NOTICED THAT THE T BAR WAS SLIGHTLY SLID DOWN GETTING CAUGHT AT TIP. THIS CONDITION MAY CONTRIBUTE TO THE BUMP AND TO THE BRAID EXPOSED OBSERVED DUE TO THE FACT THAT THE T-BAR IS APPLYING STRESS AT THAT POINT. DURING MANUFACTURING ALL THE CATHETERS ARE INSPECTED FOR VISUAL DAMAGES BEFORE PACKAGING. ON LINE INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF DAMAGE/DEFECT FROM LEAVING THE FACILITY. 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. PER THE FORCE ISSUE REPORTED THE FUNCTIONALITY OF THE BIOSENSOR CATHETER WAS TESTED ON CARTO SYSTEM. THE CATHETER FAILED DURING CARTO TEST, 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 CUSTOMER COMPLAINT REGARDING A FORCE ISSUE HAS BEEN VERIFIED. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THE T BAR ISSUE AND THE PEEK HOUSING ISSUE ON SMART TOUCH FAMILIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER, EXPERIENCED FORCE ISSUES AND THEY WERE UNABLE TO ABLATE, HOWEVER, THIS ARE NOT REPORTABLE EVENTS. THERE WAS NO PATIENT CONSEQUENCE. THIS EVENT IS BEING REPORTED BECAUSE THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND FOUND THAT PEEK HOUSING AND TIP LUMEN TRANSITION HAS A SMALL BUMP WITH METAL EXPOSED AND PU IS DAMAGED. THIS FINDING IS REPORTABLE BECAUSE METAL EXPOSED COULD POTENTIALLY CONTRIBUTE TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30658 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-01-S 16097127M

    Patients

    Seq Age Sex Outcome Treatment
    1