BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTARAY MAPPING CATHETER

    MDR report key: 18717387 · Received February 15, 2024

    Report

    Report Number
    2029046-2024-00514
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    January 22, 2024
    Report Date
    February 15, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835021127
    PMA / PMN Number
    K193237
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER AND CATHETER WAS NOT FLUSHING IRRIGATION FLUID ADEQUATELY. IT WAS REPORTED BY THE CALLER THAT THE OCTARAY MAPPING CATHETER WAS NOT FLUSHING IRRIGATION FLUID ADEQUATELY. THE BWI REPRESENTATIVE RESEATED THE TUBING AND VALVE WITHOUT RESOLUTION. THE CALLER NOTED THAT THE CATHETER WAS NOT COMPLETELY OCCLUDED AND ONLY FLUSHING A SMALL AMOUNT OF FLUID. THE BWI REPRESENTATIVE EXCHANGED THE CATHETER AND THE ISSUE RESOLVED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLTED. 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 DEVICE WAS FLUSHING CORRECTLY, NO OBSTRUCTED HOLES WERE OBSERVED. NO IRRIGATION ISSUES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTION WERE IDENTIFIED. THE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NOTE: DURING PRODUCT EVALUATION ON 20-FEB-2024, THE DEVICE LOT NUMBER WAS IDENTIFIED AS 30972382L AND FIELD D4 LOT HAS BEEN POPULATED. ADDITIONALLY, BASED ON THIS INFORMATION, THE FOLLOWING UPDATES HAVE BEEN MADE: FIELD D4. CATALOG HAS BEEN UPDATED FROM D160901 TO D160903. FIELD D4. UNIQUE IDENTIFIER( UDI) HAS BEEN UPDATED TO (B)(4). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 15-FEB-2024, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE PRODUCT 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER AND CATHETER WAS NOT FLUSHING IRRIGATION FLUID ADEQUATELY. IT WAS REPORTED BY THE CALLER THAT THE OCTARAY MAPPING CATHETER WAS NOT FLUSHING IRRIGATION FLUID ADEQUATELY. THE BWI REPRESENTATIVE RESEATED THE TUBING AND VALVE WITHOUT RESOLUTION. THE CALLER NOTED THAT THE CATHETER WAS NOT COMPLETELY OCCLUDED AND ONLY FLUSHING A SMALL AMOUNT OF FLUID. THE BWI REPRESENTATIVE EXCHANGED THE CATHETER AND THE ISSUE RESOLVED. THE ISSUE WAS NOTICED DURING THE CASE WHEN GOING BACK INTO REMAP THE ATRIUM AND NOTICED THE FLOW WAS DRIBBLING OUT WHEN FLUSHING THE CATHETER. THERE WAS NO ERROR ON PUMP, ISSUE WAS NOTICED UPON FLUSHING THE CATHETER BEFORE REINSERTING INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098893 OCTARAY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 30972382L 10846835021127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN GENERATOR.| UNK_NGEN PUMP.