BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV

    MDR report key: 22534786 · Received July 17, 2025

    Report

    Report Number
    2029046-2025-02373
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Report Date
    October 21, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012255
    PMA / PMN Number
    K123837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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

    THE INVESTIGATION WAS COMPLETED ON 02-AUG-2025. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31618498L, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON 17-JUL-2025, NOTED A CORRECTION TO THE 3500A INITIAL, UNDER THE D4. PRIMARY UDI NUMBER AS IT SHOULD HAVE BEEN PROCESSED AS (B)(4). THEREFORE, CORRECTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON 20-OCT-2025, NOTED A CORRECTION TO 3500A FOLLOW-UP #1 AS H11. ADDITIONAL MANUFACTURER NARRATIVE INCLUDED THE FOLLOWING: DURING AN INTERNAL REVIEW ON 17-JUL-2025, NOTED A CORRECTION TO THE 3500A INITIAL, UNDER THE D4. PRIMARY UDI NUMBER AS IT SHOULD HAVE BEEN PROCESSED AS (B)(4). THEREFORE, CORRECTED. HOWEVER, IN ERROR D4. PRIMARY UDI NUMBER FIELD WAS NOT POPULATED. THEREFORE, POPULATED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH PENTARAY NAV CATHETER AND THE IRRIGATION ISSUE (DURING USE ON PATIENT) ISSUE OBSERVED. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION ON 18-SEP-2025. VISUAL INSPECTION AND IRRIGATION TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. AN IRRIGATION TEST WAS PERFORMED, AND THE CATHETER FAILED THE TEST SINCE NO FLOW WAS OBSERVED. AFTERWARDS, AN ALUMINUM WIRE WAS INTRODUCED IN THE LUER HUB, AND THE WIRE GOT STUCK AT THE TIP AREA. THE TIP WAS DISSECTED AND THE IRRIGATION TUBE WAS INSPECTED, AND IT WAS FOUND THE IRRIGATION TUBE FOLDED INTO A "Z" SHAPE IN THE TRANSITION BETWEEN THE TIP TO THE SHEATH. THIS FAILURE MODE WAS IDENTIFIED AS MANUFACTURING RELATED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE IRRIGATION ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE ROOT CAUSE OF THE FOLDED IRRIGATION TUBING IS TRACED TO THE MANUFACTURING PROCESS. THE INSTRUCTION FOR USE (IFU) CONTAIN THE FOLLOWING WARNING AND PRECAUTIONS: FLUSH THE CATHETER WITH HEPARINIZED SALINE PRIOR TO INSERTION INTO THE BODY. ALWAYS FOLLOW STANDARD PRACTICES OF USING A CONTINUOUS DRIP OF ANTICOAGULANT FLUID UNDER PRESSURE THROUGH THE PROXIMAL LUER CONNECTOR WHEN THE DEVICE IS IN THE BODY. EXPLANATION OF CODES: -INVESTIGATION FINDINGS: MANUFACTURING PROCESS PROBLEM IDENTIFIED (C16) / INVESTIGATION CONCLUSIONS: CAUSE TRACED TO MANUFACTURING (D03) / COMPONENT CODE: HOSE (G04069) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿IRRIGATION ISSUE (DURING USE ON PATIENT)¿. IN ADDITION, BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE ¿MANUFACTURING¿ RELATED. -INVESTIGATION FINDINGS: OPERATIONAL PROBLEM IDENTIFIED (C13)/ INVESTIGATION CONCLUSIONS: CAUSE TRACED TO MANUFACTURING (D03) / COMPONENT CODE: HOSE (G04069) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿IRRIGATION ISSUE (DURING USE ON PATIENT)¿. IN ADDITION, BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE ¿IRRIGATION TUBE FOLDED INTO A "Z" SHAPE IN THE TRANSITION BETWEEN THE TIP TO THE SHEATH¿. 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 A CARDIAC ABLATION PROCEDURE WITH PENTARAY NAV CATHETER AND THE IRRIGATION ISSUE (DURING USE ON PATIENT) ISSUE OBSERVED. DURING THE PROCEDURE, THE FLUID IN THE INFUSION PUMP FILLED UP. A PRESSURE ALARM ALSO SOUNDED. THEREFORE, THE PENTARAY NAV CATHETER WAS REMOVED FROM THE PATIENT FOR TESTING. AFTER THE PENTARAY NAV CATHETER WAS REMOVED, IT WAS CLEAR THAT NO FLUID WAS COMING OUT OF THE PENTARAY NAV CATHETER DURING FLUSHING. IT WAS AS IF BLOCKED. AT THE BEGINNING OF THE PROCEDURE; HOWEVER, THE PENTARAY NAV CATHETER COULD BE FLUSHED. IT WAS FLUSHING AT 120 ML PER HOUR. THEREFORE, REPLACED THE PENTARAY NAV CATHETER. AFTER THAT, THE FLUSHING WORKED. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. PROVIDED FRESENIUS KABI AGILIA VOLUMAT MC INFUSION PUMP USED FOR THIS PENTARAY NAV CATHETER. THE CORRECT CATHETER SETTINGS SELECTED ON THE GENERATOR. NO ISSUES WITH THE FLOW RATE CHANGE AT THE START OF THE ABLATION. ONLY BEFORE THE ABLATION. BUT THEN THEY CHANGED THE PENTARAY NAV CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764566 PENTARAY NAV CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31618498L 10846835012255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown FRESENIUS KABI AGILIA VOLUMAT INFUSION PUMP.| UNK GENERATOR.