BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    MDR report key: 18432452 · Received January 2, 2024

    Report

    Report Number
    2029046-2024-00026
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    December 6, 2023
    Report Date
    March 4, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012224
    PMA / PMN Number
    K123837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER PHONE: (B)(6). SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 16-JAN-2024, 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 8-FEB-2024, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PERSISTENT ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. THE PATIENT WAS PREPPED IN THE CENTERS USUAL FASHION FOR A PULMONARY VEIN ISOLATION (PVI) ABLATION. AFTER ABLATION WITHIN THE LEFT ATRIUM, THE PENTARAY WAS PULLED BACK INTO THE RIGHT ATRIUM TO MAP THE SUPERIOR VENA CAVA (SVC). THE PHYSICIAN NOTICED THAT THE PENTARAY WAS NOT FLUSHING AND TOOK IT OUT OF THE BODY TO MANUALLY FLUSH. MANUAL FLUSHING DID NOT WORK AND THE PHYSICIAN CONTINUED TO USE THE PENTARAY FOR THE REMAINDER OF THE CASE. THERE WAS AN APPROXIMATE 5 MINUTE DELAY IN THE PROCEDURE. NO DAMAGE WAS NOTED ON THE PENTARAY. THE CASE CONTINUED TO COMPLETION WITHOUT ANY FURTHER DELAY. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION AND PATENCY TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. A PATENCY TEST WAS PERFORMED, AND THE IRRIGATION TUBE WAS FOUND OCCLUDED. FOR THIS REASON, A GUIDEWIRE WAS USED TO LOCATE THE OCCLUSION AREA, AND IT WAS FOUND CLOSE TO THE TIP. FURTHER INVESTIGATION REVEALED THAT THE IRRIGATION TUBE WAS BENT. THIS FAILURE COULD BE RELATED TO THE IRRIGATION ISSUE REPORTED BY THE CUSTOMER. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31068012L NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PERSISTENT ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. THE PATIENT WAS PREPPED IN THE CENTERS USUAL FASHION FOR A PULMONARY VEIN ISOLATION (PVI) ABLATION. AFTER ABLATION WITHIN THE LEFT ATRIUM, THE PENTARAY WAS PULLED BACK INTO THE RIGHT ATRIUM TO MAP THE SUPERIOR VENA CAVA (SVC). THE PHYSICIAN NOTICED THAT THE PENTARAY WAS NOT FLUSHING AND TOOK IT OUT OF THE BODY TO MANUALLY FLUSH. MANUAL FLUSHING DID NOT WORK AND THE PHYSICIAN CONTINUED TO USE THE PENTARAY FOR THE REMAINDER OF THE CASE. THERE WAS AN APPROXIMATE 5 MINUTE DELAY IN THE PROCEDURE. NO DAMAGE WAS NOTED ON THE PENTARAY. THE CASE CONTINUED TO COMPLETION WITHOUT ANY FURTHER DELAY. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627247 PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31068012L 10846835012224

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown