BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8511827 · Received April 12, 2019

    Report

    Report Number
    2029046-2019-02982
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Date of Event
    February 26, 2019
    Report Date
    March 10, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) OBSERVED FOREIGN MATERIAL UNDER A LIFTED RING OF THE CATHETER. IN THE INITIAL REPORT, THE MANUFACTURE ADDRESS WAS ERRONEOUSLY REPORTED AS (B)(4). THE CORRECT ADDRESS IS (B)(4). MANUFACTURER NAME, CITY AND STATE OF THIS REPORT HAS BEEN UPDATED. MANUFACTURE REFERENCE NO: (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) OBSERVED FOREIGN MATERIAL UNDER A LIFTED RING OF THE CATHETER. THE INVESTIGATIONAL ANALYSIS COMPLETED 5/8/2019. THE DEVICE WAS INSPECTED AND WHITE MATERIAL WAS OBSERVED UNDER RING # 1. THE RING WAS OBSERVED LIFTED AND REDDISH MATERIAL WAS OBSERVED INSIDE THE PEBAX. DEFLECTION TESTING WAS PERFORMED AND THE CATHETER FAILED. A FAILURE ANALYSIS WAS PERFORMED AND THE CATHETER WAS OBSERVED UNDER THE X RAY MACHINE AND THE T BAR WAS FOUND SLID DOWN CAUSING THE IMPROPER DEFLECTION CONDITION. IRRIGATION TESTING WAS PERFORMED AND IT WAS FOUND WITHIN SPECIFICATIONS. THE CATHETER WAS IRRIGATING CORRECTLY. NO IRRIGATION ISSUES WERE OBSERVED. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) TESTING WAS PERFORMED AND THE RESULTS SHOWED THAT THE WHITE PARTICLE IS PRIMARILY COMPOSED OF A POLYETHYLENE -BASED MATERIAL AND BARIUM SULFATE -BASED MATERIAL. THIS COMPOSITE MATERIAL IS WIDELY USED AS RADIO PACIFIER ALONG MEDICAL DEVICE INDUSTRIES. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE T BAR SLIPPAGE CANNOT BE DETERMINED. HOWEVER, AN INTERNAL CORRECTIVE ACTION WAS CREATED TO INVESTIGATE THIS ISSUE. THE ROOT CAUSE OF THE DAMAGE ALONG THE TIP CANNOT BE RELATED TO THE MANUFACTURING PROCESS SINCE THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. IT COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. SIMILAR COMPLAINTS ARE MONITORED MONTHLY. MANUFACTURE REF NO: (B)(4).

    Additional Manufacturer Narrative · 1

    THE BWI PRODUCT 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. ON (B)(6) 2019, A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND NO INTERNAL ACTIONS WERE FOUND DURING THE REVIEW. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) OBSERVED FOREIGN MATERIAL UNDER A LIFTED RING OF THE CATHETER. INITIALLY IT WAS REPORTED THAT A DEFLECTION ISSUE OCCURRED. THE CATHETER COULD NOT DEFLECT. A SECOND CATHETER WAS USED TO COMPLETE THE OPERATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE DEFLECTION ISSUE HAS BEEN ASSESSED AS NOT REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. THIS EVENT IS BEING REPORTED BECAUSE ON (B)(6) 2019, THE BWI PAL RECEIVED THE DEVICE FOR EVALUATION AND FOUND RING 1 LIFTED WITH WHITISH MATERIAL UNDERNEATH AND REDDISH MATERIAL IN THE IN THE PEBAX SLEEVE. DURING A SECOND VISUAL INSPECTION ON (B)(6) 2019, THE BWI PAL FOUND REDDISH MATERIAL IN THE PEBAX SLEEVE AND RING 1 LIFTED, EXPOSING METAL. THE OBSERVED WHITE FOREIGN MATERIAL AND LIFTED RING HAS BEEN ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE HAS BEEN RESET TO (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304165 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC 30036323L

    Patients

    Seq Age Sex Outcome Treatment
    1