BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    MDR report key: 8367028 · Received February 25, 2019

    Report

    Report Number
    2029046-2019-02728
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Date of Event
    January 8, 2019
    Report Date
    January 31, 2019
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    MTD
    UDI-DI
    10846835012255
    PMA / PMN Number
    K123837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY THE CUSTOMER THAT NOISE OCCURRED ON THE SIGNALS FROM ELECTRODES # 17, 18, 19 AND 20, ON BOTH THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM. THE CATHETER CABLE WAS REPLACED AND THE ISSUE RESOLVED, HOWEVER, THEN THEY REMOVED THE CATHETER FROM THE PATIENT¿S BODY, THE CATHETER SPINE APPEARED TO BE KINKED. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ON 1/31/2019, THE COMPLAINT PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. INITIAL VISUAL ANALYSIS IDENTIFIED ¿SPINE E KINKED UPON INITIAL INSPECTION. RINGS # 17, 18, 19, 20 WERE SQUASHED AND DENTED AND RING # 20 BEING LIFTED WITH A SHARP EDGE.¿ THE FINDING OF RINGS BEING LIFTED WITH SHARP EDGES IS CONSIDERED AN MDR REPORTABLE MALFUNCTION. DEVICE EVALUATION DETAILS: THE DEVICE EVALUATION HAS BEEN COMPLETED. THE DEVICE WAS VISUALLY INSPECTED AND THE SPINE WAS FOUND KINKED AND THE RINGS #17, 18, 19, 20 WERE FOUND DENTED AND SQUASHED, THE RING #20 WAS FOUND LIFTED AND WITH A SHARP EDGE. THEN, ELECTRICAL TEST WAS PERFORMED AND THE CATHETER FAILED, NO ELECTRICAL READINGS WERE OBSERVED ON ELECTRODE # 18 AND #19. A FAILURE ANALYSIS WAS PERFORMED AND THE CATHETER WAS DISSECTED AND THE ELECTRICAL WIRE WERE FOUND BROKEN CAUSING THE IMPROPER ELECTRICAL SIGNAL FROM THE TIP TO THE CONNECTOR. ADDITIONALLY, ON 2/26/2019 A SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS TEST WAS PERFORMED ON THE DAMAGE AREA AND THE RESULTS SHOWED MECHANICAL DAMAGE ON THE SURFACE OF THE RING WITH A LIFTED EDGE. 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 NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE ELECTRICAL WIRE BREAKAGE CANNOT BE DETERMINED. THE ROOT CAUSE OF THE DAMAGE OBSERVED ON THE SPINES CANNOT BE DETERMINED 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, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. MANUFACTURER¿S REF #: (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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30120382L NUMBER, AND NO NON-CONFORMANCES WAS FOUND DURING THE REVIEW. MANUFACTURE REF # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. BIOSENSE WEBSTER INC. (BWI) HAS IDENTIFIED AN MDR REPORTABLE MALFUNCTION AS THE RETURNED PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER HAD ¿THE ELECTRODE RINGS # 17, 18, 19, 20 SQUASHED AND DENTED ALONG WITH RING # 20 BEING LIFTED WITH A SHARP EDGE.¿ IT WAS REPORTED BY THE CUSTOMER THAT NOISE OCCURED ON THE SIGNALS FROM ELECTRODES # 17, 18, 19 AND 20, ON BOTH THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM. THE CATHETER CABLE WAS REPLACED AND THE ISSUE RESOLVED, HOWEVER, THEN THEY REMOVED THE CATHETER FROM THE PATIENT¿S BODY, THE CATHETER SPINE APPEARED TO BE KINKED. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE INITIALLY REPORTED ISSUES OF NOISE AND A KINK ARE NOT MDR REPORTABLE SINCE THE POTENTIAL RISK THAT THESE ISSUES COULD CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY OR OTHER SIGNIFICANT ADVERSE EVENT IS REMOTE. ON 1/31/2019, THE COMPLAINT PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. INITIAL VISUAL ANALYSIS IDENTIFIED ¿SPINE E KINKED UPON INITIAL INSPECTION. RINGS # 17, 18, 19, 20 WERE SQUASHED AND DENTED AND RING # 20 BEING LIFTED WITH A SHARP EDGE.¿ THE FINDING OF RINGS BEING LIFTED WITH SHARP EDGES IS CONSIDERED AN MDR REPORTABLE MALFUNCTION. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A REPORTABLE MALFUNCTION THROUGH INITIAL VISUAL ANALYSIS ON 01/31/2019 AND HAS REASSESSED THIS COMPLAINT AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159525 PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC. 30120382L 10846835012255

    Patients

    Seq Age Sex Outcome Treatment
    1