BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 8524912 · Received April 17, 2019

    Report

    Report Number
    2029046-2019-03001
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Date of Event
    December 20, 2018
    Report Date
    December 23, 2018
    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 FOR ATRIAL FIBRILLATION (AFIB) WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) FOUND A HOLE BETWEEN THE PEAK HOUSING AND ELECTRODE. IN THE INITIAL REPORT, THE MANUFACTURE ADDRESS WAS ERRONEOUSLY REPORTED AS 31 TECHNOLOGY DR. IRVINE, CA 92618. THE CORRECT ADDRESS IS 33 TECHNOLOGY DR. IRVINE , CA 92618. MANUFACTURE REF NO: (B)(4) .

    Additional Manufacturer Narrative · 1

    THE INVESTIGATIONAL ANALYSIS COMPLETED ON 3/21/2019. THE DEVICE WAS INSPECTED AND THE PEEK HOUSING WAS OBSERVED KINKED AND THE ELECTRODE DAMAGED, WITHOUT SHARP EDGES. DEFLECTION TESTING WAS PERFORMED AND THE CATHETER FAILED. A FAILURE ANALYSIS WAS PERFORMED AND THE CATHETER WAS OBSERVED UNDER THE X RAY MACHINE. THE T BAR WAS FOUND SLID DOWN CAUSING THE IMPROPER DEFLECTION CONDITION. SCANNING ELECTRON MICROSCOPE (SEM) TESTING WAS PERFORMED ON THE DAMAGED AREA. THE RESULTS SHOWED EVIDENCE OF MECHANICAL DAMAGE, SCRATCHES AND A HOLE BETWEEN THE PEEK HOUSING AND ELECTRODE. IT IS POSSIBLE THAT THE DAMAGE WAS GENERATED WITH AN UNKNOWN OBJECT. NO OTHER ANOMALIES WERE OBSERVED. 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 ON THE PEEK HOUSING AND THE ELECTRODE DAMAGE CANNOT BE RELATED TO THE MANUFACTURE 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. MANUFACTURE REFERENCE NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION (AFIB) WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) FOUND A HOLE BETWEEN THE PEAK HOUSING AND ELECTRODE. INITIALLY IT WAS REPORTED THAT A DEFLECTION ISSUE OCCURRED. CATHETER REPLACEMENT RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED AND NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE DEFLECTION ISSUE WAS ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. ON 1/31/2019, THE BWI PAL RECEIVED THE DEVICE FOR EVALUATION. UPON INITIAL INSPECTION, KINKED PEAK HOUSING AND ELECTRODE DAMAGE WITH NO SHARP RINGS WERE OBSERVED. A SECOND VISUAL INSPECTION WAS PERFORMED ON 3/21/2019 AND CONFIRMED THE INITIAL FINDINGS OF KINKED PEAK HOUSING AND ELECTRODE DAMAGE WITH NO SHARP RINGS. THE INITIAL AND SECONDARY VISUALLY OBSERVED FINDINGS OF ELECTRODE DAMAGE HAS BEEN ASSESSED AS NOT MDR REPORTABLE AS THE DAMAGED ELECTRODE WAS WITHOUT SHARP EDGES. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. FURTHER TESTING WAS PERFORMED. ON 3/21/2019, SCANNING ELECTRON MICROSCOPE ANALYSIS WAS PERFORMED AND THE BWI PAL FOUND EVIDENCE OF MECHANICAL DAMAGE, SCRATCHES, AND A HOLE BETWEEN THE PEAK HOUSING AND ELECTRODE. THE OBSERVED HOLE HAS BEEN ASSESSED AS MDR REPORTABLE. THE ALERT DATE HAS BEEN RESET TO 3/21/2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315516 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC 30067467M

    Patients

    Seq Age Sex Outcome Treatment
    1