BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    MDR report key: 15933446 · Received December 7, 2022

    Report

    Report Number
    2029046-2022-03043
    Event Type
    Malfunction
    Date Received
    December 7, 2022
    Date of Event
    August 17, 2022
    Report Date
    December 5, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012224
    PMA / PMN Number
    K123837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE: (B)(6). THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE ON 31-OCT-2022. THE DEVICE EVALUATION WAS COMPLETED ON 08-NOV-2022. A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL INVESTIGATION WAS PERFORMED, AND ONE ELECTRODE WAS OBSERVED LIFTED WITHOUT PU (POLYURETHANE) ON THE EDGE. A DIMENSIONAL TEST WAS PERFORMED, AND THE OUTER DIAMETERS OF THE DEVICE WERE FOUND WITHIN SPECIFICATIONS. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED SINCE THE DAMAGE ON THE ELECTRODE COULD BE RELATED TO THE IMPEDED ISSUE. THE ELECTRODE DAMAGE COULD BE RELATED TO THE INTERACTION BETWEEN THE DEVICE AND THE USED SHEATH HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 30711973L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT 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 AN UNKNOWN ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB OBSERVED THAT ONE ELECTRODE WAS LIFTED WITHOUT PU (POLYURETHANE) ON THE EDGE. INITIALLY, IT WAS REPORTED THAT THE ¿PENTARAY DID NOT GO INTO THE LONG SWEAT OF THE FOREWORD WITH THE CODE 301803M¿. HE DID NOT GET INTO THE PROXIMAL RING. A NEW TRANSEPTAL SHEATH WAS OPENED, THE PROBLEM PERSISTED. A NEW PENTARAY WAS USED, AND THE PROBLEM SOLVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE IMPEDED DEVICE 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 ONE ELECTRODE WAS OBSERVED LIFTED WITHOUT PU (POLYURETHANE) ON THE EDGE. THIS FINDING WAS ASSESSED AS MDR REPORTABLE. THEREFORE, THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS 08-NOV-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815236 PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC D128208 30711973L 10846835012224

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK TRANSSEPTAL SHEATH| UNK TRANSSEPTAL SHEATH| UNK_PENTARAY