BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6983553 · Received October 27, 2017

    Report

    Report Number
    9673241-2017-00695
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    June 22, 2017
    Report Date
    June 22, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED DEVICE WAS VISUALLY INSPECTED AND ONE RING WAS OBSERVED LIFTED, SHARP AND FOREIGN MATERIAL WAS OBSERVED UNDERNEATH THE RING. PER THE CONDITION OBSERVED, THE CATHETER OUTER DIAMETER WAS MEASURED AND IT WAS FOUND WITHIN SPECIFICATIONS. PER THE COMPLAINT, THE CATHETER WAS TESTED FOR DEFLECTION AND THE CATHETER FAILED. THE CATHETER WAS DISSECTED AND RESIDUES OF POLYURETHANE (PU) APPLICATION WAS FOUND AT THE T-BAR ANCHORED PLACE WHICH INDICATES A PROPER MANUFACTURING ASSEMBLY. ADDITIONALLY, CATHETER DEFLECTION IS VERIFIED SEVERAL TIMES BEFORE LEAVING THE FACILITIES. PER MATERIAL OBSERVED, A FOURIER TRANSFORM INFRARED SPECTROSCOPY (FT-IR) WAS PERFORMED AND THE RESULTS SHOWED THAT THE MATERIAL FOUND WAS IDENTIFIED TO BE PRIMARILY COMPOSED OF POLYETHYLENE AND BARIUM SULFATE; A PLASTIC COMPOSITE WIDELY USED ON MEDICAL DEVICE INDUSTRIES. 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. DURING THE MANUFACTURING PROCESS, ALL THE CATHETERS ARE INSPECTED FOR VISUAL DAMAGES BEFORE PACKAGING. ON LINE INSPECTIONS AND FUNCTIONAL TESTS ARE IN PLACE TO PREVENT THIS TYPE OF DAMAGE FROM LEAVING THE FACILITY. THE CUSTOMER COMPLAINT HAS BEEN VERIFIED. THE ROOT CAUSE OF THE CATHETER T-BAR DISPLACEMENT CANNOT BE DETERMINED SINCE THERE WAS EVIDENCE OF THE PROPER MANUFACTURING ASSEMBLY. BASED ON AVAILABLE ANALYSIS FINDING RESULTS, THE DAMAGE DOES NOT APPEAR TO BE CAUSED BY ANY INTERNAL BIOSENSE WEBSTER, INC. PROCESSES. SINCE THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES, IT COULD BE RELATED TO THE MANIPULATION OF THE CATHETER WITHIN THE SHEATH. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A SMART TOUCH UNIDIRECTIONAL CATHETER. INITIALLY IT WAS REPORTED THAT DURING THE PROCEDURE, THE SMART TOUCH UNIDIRECTIONAL CATHETER COULD NOT DEFLECT. THE CATHETER WAS CHANGED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES. THIS DEFLECTION ISSUE WAS ASSESSED AS NOT REPORTABLE. SINCE THE CATHETER WAS UNABLE TO DEFLECT, THE USER WILL NOT BE ABLE TO USE THE DEVICE AND WILL HAVE TO REPLACE IT. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH WAS REMOTE. THE BIOSENSE WEBSTER FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. ON (B)(6) 2017, IT WAS DISCOVERED THAT THE 2ND ELECTRODE RING WAS OBSERVED LIFTED, SHARP AND FOREIGN MATERIAL WAS OBSERVED UNDERNEATH IT. THIS RETURNED CATHETER CONDITION OF THE ELECTRODE RING BEING LIFTED, SHARP WITH THE FOREIGN MATERIAL WERE ASSESSED AS A REPORTABLE. THE AWARENESS DATE WAS (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764711 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-04IL-S 17651322M

    Patients

    Seq Age Sex Outcome Treatment
    1