BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV

    MDR report key: 20016591 · Received August 21, 2024

    Report

    Report Number
    2029046-2024-02719
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    July 22, 2024
    Report Date
    September 14, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012224
    PMA / PMN Number
    K123837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION 14-AUG-2024. 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. 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).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A PENTARAY NAV CATHETER. WHEN RE-INSERTING THE PENTARAY NAV CATHETER BACK INTO THE BODY, IT WAS NOTICED THAT THE PENTARAY NAV CATHETER WAS NOT IRRIGATING AT ALL. AFTER HIGH-FLOW FLUSHING THE PENTARAY NAV CATHETER, THE ISSUE STILL PERSISTED. THE PENTARAY NAV CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE EVALUATION WAS COMPLETED ON 23-AUG-2024. THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION AND IRRIGATION TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. AN IRRIGATION TEST WAS PERFORMED, AND THE CATHETER FAILED THE TEST SINCE THE IRRIGATION TUBE WAS FOUND BENT INSIDE THE SHAFT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE IRRIGATION ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE BENT COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: FLUSH THE CATHETER WITH HEPARINIZED SALINE PRIOR TO INSERTION INTO THE BODY. AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. DURING AN INTERNAL REVIEW ON 14-SEP-2024, NOTED A CORRECTION TO THE 3500A INITIAL UNDER D4. PRIMARY UDI NUMBER. IT SHOULD HAVE BEEN PROCESSED AS (B)(4). 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 A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A PENTARAY NAV CATHETER AND AN IRRIGATION ISSUE OCCURRED DURING USE ON THE PATIENT. WHEN RE-INSERTING THE PENTARAY NAV CATHETER BACK INTO THE BODY, IT WAS NOTICED THAT THE PENTARAY NAV CATHETER WAS NOT IRRIGATING AT ALL. AFTER HIGH-FLOW FLUSHING THE PENTARAY NAV CATHETER, THE ISSUE STILL PERSISTED. THE PENTARAY NAV CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014389 PENTARAY NAV CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31345602L 10846835012224

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NGEN GENERATOR.| QDOT MICRO, BI, TC, D-F.| UNK CABLE.| UNK RECORDING SYSTEM.| UNK_CARTO 3.