BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15903134 · Received December 2, 2022

    Report

    Report Number
    2029046-2022-03020
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    August 12, 2022
    Report Date
    December 1, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE: (B)(6). THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE ON 03-OCT-2022. THE DEVICE EVALUATION WAS COMPLETED ON 03-NOV-2022. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED A CUT AND REDDISH MATERIAL IN THE PEBAX. THE ROOT CAUSE OF THE DAMAGE ON PEBAX CANNOT BE RELATED TO THE MANUFACTURING PROCESS SINCE THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES, IT COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30822248L NUMBER, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB OBSERVED A CUT IN THE PEBAX. INITIALLY, IT WAS REPORTED THAT AFTER THE INSERTION OF THE CATHETER TO THE BODY, AND ABOUT SEVERAL MINUTES AFTER THE INSERTION, BLOOD CONTAMINATED BETWEEN THE SECOND AND THIRD POLES OF THE CATHETER. THIS WAS NOT A NORMAL SITUATION, SO THE CATHETER WAS REPLACED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THE FOREIGN MATERIAL INSIDE THE PEBAX - NO EXTERNAL DAMAGE 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. THIS EVENT IS BEING REPORTED BECAUSE THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND FOUND THAT THERE WAS A CUT AND REDDISH MATERIAL IN THE PEBAX. THIS FINDING WAS ASSESSED AS MDR REPORTABLE. THEREFORE, THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS 03-NOV-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396371 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30822248L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK BRAND CATHETER