BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    MDR report key: 19493404 · Received June 8, 2024

    Report

    Report Number
    2029046-2024-01869
    Event Type
    Malfunction
    Date Received
    June 8, 2024
    Date of Event
    March 7, 2024
    Report Date
    June 7, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012255
    PMA / PMN Number
    K123837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E 1. INITIAL REPORTER PHONE: (B)(6). THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING BWI PROCEDURES. VISUAL INSPECTION WAS PERFORMED, AND ONE SPLINE WAS OBSERVED BEND. IN ADDITION, ONE OF THE ELECTRODES OF THE SPLINE WAS OBSERVED LIFTED AND SHARP, BUT NO INTERNAL COMPONENTS WERE EXPOSED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31082958L AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE TIP AND ENTRAPMENT ISSUES REPORTED BY THE CUSTOMER WERE CONFIRMED. THE POTENTIAL CAUSE OF THE ISSUE COULD BE RELATED TO EXCESSIVE FORCE OR MANIPULATION DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE CONTAIN (IFU) THE FOLLOWING WARNING AND PRECAUTION: 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. DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER THROUGH THE GUIDING SHEATH WHEN RESISTANCE IS ENCOUNTERED. PRIOR TO REMOVING OR REPOSITIONING THE CATHETER, USE DIRECT IMAGING GUIDANCE SUCH AS FLUOROSCOPY TO CONFIRM THAT THE SPINE ASSEMBLY IS NOT ENTANGLED WITH ANOTHER CATHETER OR WITH AN ANATOMICAL STRUCTURE. AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH BWI'S QUALITY SYSTEM. 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 A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) OBSERVED THAT ONE OF THE ELECTRODES OF THE SPLINE WAS LIFTED AND SHARP. INITIALLY, IT WAS REPORTED THAT ONE OF THE SPLINES GOT STUCK DURING SHEATHING IN AND OUT, WHICH CAUSED THE SPLINE TO BEND. THE PENTARAY WAS REPLACED WITH A NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS INDICATED THAT THERE WERE NO WIRES BEING EXPOSED AND NO LIFTED OR SHARP RINGS WERE OBSERVED BY THE REPORTER. THERE WAS RESISTANCE DURING THE REMOVAL OF THE CATHETER. THE CATHETER WAS NOT PRE-SHAPED. THE CATHETER WAS ABLE TO MOVE THROUGH THE SHEATH. THE BENT TIP AND SPLINES GETTING STUCK IN THE SHEATH WERE 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. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION ON 11-MAY-2024, ONE OF THE ELECTRODES OF THE SPLINE WAS OBSERVED LIFTED AND SHARP, BUT NO INTERNAL COMPONENTS WERE EXPOSED. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 11-MAY-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2325859 PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31082958L 10846835012255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown VIZIGO LONG, 8.5 FR.