BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 9447898 · Received December 10, 2019

    Report

    Report Number
    2029046-2019-03979
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    November 2, 2019
    Report Date
    November 15, 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

    INVESTIGATION SUMMARY IT WAS REPORTED A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB DISCOVERED THAT THE DISTAL TIP WAS BENT AND PARTIALLY DETACHED. INITIALLY IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER COULD NOT DEFLECT TO ITS SPECIFICATIONS. THE ISSUE WAS RESOLVED BY CHANGING THE CATHETER TO ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. THE DEVICE WAS INSPECTED, AND THE DISTAL TIP WAS FOUND PARTIALLY DETACHED. IN ADDITION, POLYURETHANE (PU) WAS OBSERVED ON THE EDGE. A DEFLECTION TEST WAS PERFORMED, AND THE CATHETER PASSED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30163225M NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. ADDITIONALLY, THE CUSTOMER PROVIDED A PHOTO OF THE PRODUCT BOX. AN EVALUATION WAS PERFORMED; HOWEVER, NO RESULT CAN BE OBTAINED FROM IT. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE OF THE DAMAGE ON THE TIP COULD BE RELATED TO THE SHIPPING/HANDLING OF THE DEVICE HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON NOVEMBER 15, 2019. 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. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB DISCOVERED THAT THE DISTAL TIP WAS BENT AND PARTIALLY DETACHED. INITIALLY IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER COULD NOT DEFLECT TO ITS SPECIFICATIONS. THE ISSUE WAS RESOLVED BY CHANGING THE CATHETER TO ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. THE CURVE INADEQUATE ISSUE WAS ASSESSED AS NOT REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE INITIAL VISUAL INSPECTION OF THE PRODUCT REVEALED THAT DISTAL TIP WAS BENT AND PARTIALLY DETACHED. DURING THE SECOND VISUAL INSPECTION ON NOVEMBER 25, 2019, THE DEVICE WAS INSPECTED, AND IT WAS CONFIRMED THAT DISTAL TIP WAS BENT AND PARTIALLY DETACHED. IT WAS ALSO FOUND THERE WAS POLYURETHANE WAS OBSERVED ON THE EDGES. IT WAS CONFIRMED THAT THE INTEGRITY OF THE DEVICE WAS COMPROMISED. THESE FINDINGS WERE REVIEWED AND DETERMINED TO BE MDR REPORTABLE AS A MALFUNCTION. THIS EVENT WAS ORIGINALLY CONSIDERED NOT MDR REPORTABLE, HOWEVER, BIOSENSE WEBSTER, INC. BECAME AWARE OF A REPORTABLE MALFUNCTION THROUGH VISUAL ANALYSIS AND TESTING ON NOVEMBER 15, 2019 AND HAVE REASSESSED THIS COMPLAINT AS REPORTABLE. THEREFORE, THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS NOVEMBER 15, 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238193 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC 30163225M

    Patients

    Seq Age Sex Outcome Treatment
    1