BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    MDR report key: 19245088 · Received May 4, 2024

    Report

    Report Number
    2029046-2024-01468
    Event Type
    Malfunction
    Date Received
    May 4, 2024
    Date of Event
    April 8, 2024
    Report Date
    June 21, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012255
    PMA / PMN Number
    K123837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 29-APR-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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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 AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. AFTER REINSERTING THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER INTO THE BODY FOR THE SECOND TIME, IT MAY HAVE BEEN CAUGHT ON THE VIZIGO SHEATH OR SOMETHING ELSE, BUT ONE OF THE SPLINES WAS DISPLAYING NOISE ON BOTH CARTO® 3 AND THE RECORDING SYSTEM AND WAS NOT VISUALIZING ON THE SCREEN. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE SPLINE HAD PHYSICAL DAMAGE. IT SEEMED AS THOUGH THE ELECTRODE AND THE SPLINE WERE ALMOST FULLY DETACHED FROM EACH OTHER. LIKE IT WAS PINCHED. WHILE REINSERTING THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER, THE PHYSICIAN STATED THAT THERE WAS NO EXTRA RESISTANCE WHEN PLACED AGAIN INTO THE VIZIGO SHEATH. UNFORTUNATELY, NOT ABLE TO CAPTURE AN IMAGE. THE DEVICE EVALUATION WAS COMPLETED ON 27-MAY-2024. THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION, MAGNETIC SENSOR FUNCTIONALITY TEST AND ELECTRICAL EVALUATION OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED THAT SOME ELECTRODES WERE LIFTED AND BENT, LETTING EXPOSED WIRES ON THE DEVICE. THE DEVICE WAS CONNECTED TO THE CARTO 3 SYSTEM AND IT WAS RECOGNIZED; HOWEVER, THE DEVICE WAS NOT VISUALIZED SINCE ERROR 116 WAS DISPLAYED ON THE SCREEN DUE TO AN OPEN CIRCUITS ON THE TIP AREA AND THE LIFTED AND BENT ELECTRODES. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE ELECTRODE DAMAGE, VISUALIZATION AND ELECTRICAL ISSUES REPORTED BY THE CUSTOMER WERE CONFIRMED. THE POTENTIAL CAUSE OF THE OPEN CIRCUITS COULD NOT BE CONCLUSIVELY DETERMINED. THE POTENTIAL CAUSE OF THE LIFTED AND BENT ELECTRODES COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTION FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: THE CATHETER IS RECOMMENDED FOR USE WITH AN 8 F GUIDING SHEATH BECAUSE THE DISTAL SPLINES MAY BE DAMAGED IF USED WITH A SHEATH THAT IS NOT COMPATIBLE; CAREFUL MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. CATHETER ADVANCEMENT AND PLACEMENT SHOULD BE DONE UNDER DIRECT IMAGING GUIDANCE (SUCH AS FLUOROSCOPY OR ULTRASOUND) THROUGH A GUIDING SHEATH. IN ADDITION, EXTRA CARE SHOULD BE TAKEN WHILE INSERTING, ASPIRATING, AND MANIPULATING THE GUIDING SHEATH. 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. EXPLANATION OF CODES: -INVESTIGATION FINDINGS: OPEN CIRCUIT (C0205) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: ELECTRICAL LEAD/WIRE (G02015) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿NOISE¿ ISSUE. -INVESTIGATION FINDINGS: OPEN CIRCUIT (C0205) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: SENSOR (G03012) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿VISUALIZATION¿ ISSUE. -INVESTIGATION FINDINGS: STRESS PROBLEM IDENTIFIED (C0706) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: RING (G04111) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿THE ELECTRODE AND THE SPLINE WERE ALMOST FULLY DETACHED FROM EACH OTHER¿. 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 AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND ELECTRODE AND THE SPLINE ALMOST FULLY DETACHED FROM EACH OTHER (LIKE PINCHED) ISSUE OCCURRED. AFTER REINSERTING THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER INTO THE BODY FOR THE SECOND TIME, IT MAY HAVE BEEN CAUGHT ON THE VIZIGO SHEATH OR SOMETHING ELSE, BUT ONE OF THE SPLINES WAS DISPLAYING NOISE ON BOTH CARTO® 3 AND THE RECORDING SYSTEM AND WAS NOT VISUALIZING ON THE SCREEN. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 09-APR-2024. THE SPLINE HAD PHYSICAL DAMAGE. IT SEEMED AS THOUGH THE ELECTRODE AND THE SPLINE WERE ALMOST FULLY DETACHED FROM EACH OTHER. LIKE IT WAS PINCHED. WHILE REINSERTING THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER, THE PHYSICIAN STATED THAT THERE WAS NO EXTRA RESISTANCE WHEN PLACED AGAIN INTO THE VIZIGO SHEATH. UNFORTUNATELY, NOT ABLE TO CAPTURE AN IMAGE. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF THE ELECTRODE AND THE SPLINE ALMOST FULLY DETACHED FROM EACH OTHER (LIKE PINCHED) ON 09-APR-2024 AND HAVE REASSESSED THE EVENT AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 09-APR-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123114 PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31138893L 10846835012255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NGEN RF GENERATOR, US.| UNK RECORDING SYSTEM.| UNK_CARTO 3.| UNK_CARTO VIZIGO SHEATH.