BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV

    MDR report key: 20710770 · Received November 18, 2024

    Report

    Report Number
    2029046-2024-03713
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    September 9, 2024
    Report Date
    November 18, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012255
    PMA / PMN Number
    K123837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL ANALYSIS REVEALED THAT THE SPLINE WAS BENT AND SOME ELECTRODES OF THE SPLINE WERE LIFTED. THE SPLINE BENT ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE BENT SPLINE COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE, HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 30767794LN AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE INSTRUCTION FOR USE OF THE DEVICE CONTAIN THE FOLLOWING RECOMMENDATIONS: DO NOT INTRODUCE THE CATHETER INTO A GUIDING SHEATH WITH THE CATHETER¿S DISTAL SPINES FOLDED BACKWARD TOWARD THE HANDLE. COLLAPSE THE SPINES TOGETHER USING THE INSERTION TUBE PRIOR TO INSERTION; THE CATHETER IS RECOMMENDED FOR USE WITH AN 8 F GUIDING SHEATH BECAUSE THE DISTAL SPINES MAY BE DAMAGED IF USED WITH A SHEATH THAT IS NOT COMPATIBLE. DO NOT USE THE CATHETER IN CONJUNCTION WITH TRANSSEPTAL SHEATHS FEATURING SIDE HOLES LARGER THAN 1.25 MM IN DIAMETER; DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER THROUGH THE GUIDING SHEATH WHEN RESISTANCE IS ENCOUNTERED; ADVANCE THE INSERTION TUBE ALONG THE CATHETER SHAFT TO COLLAPSE THE SPINES TOGETHER PRIOR TO INSERTION INTO THE SHEATH (SEE ILLUSTRATION). DO NOT BEND THE SPINES BACKWARD. AFTER INSERTION, SLIDE THE INSERTION TUBE BACK TOWARD THE HANDLE. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) CARDIAC PROCEDURE WITH A PENTARAY NAV FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THAT THE SPLINE WAS BENT AND SOME ELECTRODES OF THE SPLINE WERE LIFTED. INITIALLY, IT WAS REPORTED THAT THE CATHETER SPLINE ICON APPEARED DEFORMED. IT WAS TAKEN OUT OF THE VIZIGO SHEATH AND THE SPLINE WAS BROKE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE SPLINE ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT WAS REMOTE. THE BIOSENSE WEBSTER, INC. PAL RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION ON 22-OCT-2024, SPLINE WAS BENT AND SOME ELECTRODES OF THE SPLINE WERE LIFTED. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 22-OCT-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2037751 PENTARAY NAV CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 30767794LN 10846835012255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8.5F SHEATH WITH CURVE VIZ SMC| PENTARAY NAV ECO 7FR, D, 2-6-2| UNK_NGEN RF GENERATOR