BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    MDR report key: 9656945 · Received February 2, 2020

    Report

    Report Number
    2029046-2020-00169
    Event Type
    Malfunction
    Date Received
    February 2, 2020
    Date of Event
    October 21, 2019
    Report Date
    October 21, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012255
    PMA / PMN Number
    K123837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT A PATIENT UNDERWENT THAT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER FOR WHICH THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB FOUND A BROKEN TIP. INITIALLY IT WAS REPORTED THAT DURING THE PROCEDURE, THE MAGNETIC SENSOR ERROR 106 WAS DISPLAYED. THE CATHETER WAS REPLACED WITH A SECOND CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED TO THE PATIENT. THE DEVICE WAS VISUALLY INSPECTED AND ONE OF THE SPLINES WAS MISSING. THEREFORE, THE MAGNETIC SENSOR FUNCTIONALITY TESTING COULD NOT BE EVALUATED DUE TO RETURNED CATHETER CONDITION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30238624L NUMBER, AND NO INTERNAL ACTIONS WAS FOUND DURING THE REVIEW. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE OF THE SPLINE DETACHED 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 OF THE DEVICE DURING THE SHIPMENT; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. MANUFACTURER'S REFERENCE # (B)(4).

    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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT THAT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER FOR WHICH THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB FOUND A BROKEN TIP. INITIALLY IT WAS REPORTED THAT DURING THE PROCEDURE, THE MAGNETIC SENSOR ERROR 106 WAS DISPLAYED. THE CATHETER WAS REPLACED WITH A SECOND CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED TO THE PATIENT. ON JANUARY 7, 2020, THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION, AND IT WAS NOTED THAT UPON INITIAL VISUAL INSPECTION IT WAS FOUND THAT A PART OF ONE OF THE CATHETER SPLINES IS MISSING. THIS EVENT WAS ORIGINALLY CONSIDERED NOT MDR REPORTABLE, HOWEVER, BIOSENSE WEBSTER, INC. BECAME AWARE OF A REPORTABLE MALFUNCTION THROUGH SECOND VISUAL ANALYSIS ON JANUARY 7, 2020 AND HAVE REASSESSED THIS COMPLAINT AS REPORTABLE. THEREFORE, THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS JANUARY 7, 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120095 PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC D128211 30238624L 10846835012255

    Patients

    Seq Age Sex Outcome Treatment
    1