BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8867559 · Received August 6, 2019

    Report

    Report Number
    2029046-2019-03519
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Date of Event
    July 9, 2019
    Report Date
    July 9, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010176
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT, UNDERWENT AN ABLATION PROCEDURE WITH THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER, AND THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) FOUND A A CUT IN SHAFT ABOUT 3 CM FROM DISTAL TIP AND INTERNAL PARTS WERE EXPOSED. THE INVESTIGATIONAL ANALYSIS COMPLETED (B)(6)2019. THE DEVICE WAS RETURNED, AND THE CATHETER TIP WAS OBSERVED CUT WITH INTERNAL PARTS EXPOSED. THERE APPEARED TO BE A CUT IN SHAFT, ABOUT 3 CM FROM DISTAL TIP. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE ROOT CAUSE OF THE DAMAGE ON THE CATHETER 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 AND MANIPULATION DURING THE SHIPMENT OF THE DEVICE. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. MANUFACTURE REFERENCE NO: PC-000508261.

    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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND NO INTERNAL ACTIONS WERE FOUND DURING THE REVIEW. MANUFACTURE REFERENCE NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, UNDERWENT AN ABLATION PROCEDURE WITH THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER, AND THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) FOUND A CUT IN SHAFT ABOUT 3 CM FROM DISTAL TIP AND INTERNAL PARTS WERE EXPOSED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE OBSERVED CUT SHAFT HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION AS THE DEVICE INTEGRITY WAS COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660698 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30130772L 10846835010176

    Patients

    Seq Age Sex Outcome Treatment
    1