BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV

    MDR report key: 20285412 · Received September 23, 2024

    Report

    Report Number
    2029046-2024-03181
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    June 27, 2024
    Report Date
    September 23, 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 CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL INSPECTION WAS PERFORMED, AND ONE SPLINE WAS OBSERVED BENT. IN ADDITION, ONE OF THE ELECTRODES OF THE SPLINE WAS OBSERVED LIFTED AND SHARP, WITH NO INTERNAL COMPONENTS WERE EXPOSED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE TIP AND RESISTANCE 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 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 (ATRIAL FIBRILLATION, PAROXYSMAL) PROCEDURE WITH A PENTARAY NAV FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED ONE OF THE ELECTRODES OF THE SPLINE WAS LIFTED AND IT WAS SHARP. INITIALLY, IT WAS REPORTED THAT WHEN ATTEMPTING TO REINSERT THE PENTARAY CATHETER, IT COULD NOT BE ADVANCED THROUGH THE VIZIGO SHEATH HUB. THE SPLINES WERE DAMAGED IN THE PROCESS. THE CATHETER WAS EXCHANGED TO CONTINUE THE CASE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE RESISTANCE WITH SHEATH AND THE DAMAGED SPLINES 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. PAL RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION ON 26-AUG-2024, ONE OF THE ELECTRODES OF THE SPLINE WAS OBSERVED LIFTED AND SHARP WITH NO INTERNAL COMPONENTS EXPOSED. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 26-AUG-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746304 PENTARAY NAV CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31322592L 10846835012224

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BS CABLES SET,2M TRUNK + LEADS| CARTO 3 SYSTEM| UNK_CARTO VIZIGO SHEATH| UNK_SMARTABLATE GENERATOR