BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    MDR report key: 19683883 · Received July 5, 2024

    Report

    Report Number
    2029046-2024-02264
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    January 1, 2024
    Report Date
    August 21, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012224
    PMA / PMN Number
    K123837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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

    CORRECTION TO THE INITIAL REPORT: FULL UDI HAS BEEN POPULATED TO FIELD D4. PRIMARY UDI NUMBER. DENSITY MAPPING ECO CATHETER AND THE PHYSICIAN TRIED TO IRRIGATE THE CATHETER BY CONNECTING THE PRESSURE BAG; HOWEVER, SALINE DID NOT COME OUT AT THE END OF THE CATHETER. THEY INCREASED THE PRESSURE, AND THIS DID NOT RESOLVE THE ISSUE. THE PHYSICIAN TRIED AGAIN WITH A SYRINGE, AND IT DID NOT IRRIGATE. AFTER REPLACING THE CATHETER, THE ISSUE WAS RESOLVED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE WAS NOTED WHEN THE DEVICE WAS INSERTED INTO THE PATIENT¿S BODY (ABOUT 10 MINUTES). THE PHYSICIAN TOOK OUT THE DEVICE FOR ABLATION AND NOTED THAT IT WAS NOT IRRIGATED. THERE WAS NO ELECTRIC PUMP THAT WAS CONNECTED TO THE PENTARAY CATHETER. IT WAS ONLY THE MANUAL SALINE PRESSER BAG THAT WAS CONNECTED. WHEN THE PHYSICIAN CHECKED THE CATHETER TO PUT IT BACK INTO THE BODY AFTER ABLATION, IT WAS CONFIRMED THAT IT DID NOT IRRIGATE. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION AND IRRIGATION TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. AN IRRIGATION TEST WAS PERFORMED, AND AN OCCLUSION WAS FOUND. FOR THIS REASON, A GUIDEWIRE WAS USED TO LOCATE THE OCCLUSION AREA, AND IT WAS FOUND CLOSE TO THE TIP. FURTHER INVESTIGATION REVEALED REDDISH MATERIAL OCCLUDING THE IRRIGATION TUBE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31192918L NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE IRRIGATION ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE OCCLUSION IN THE IRRIGATION TUBE COULD BE RELATED TO THE USAGE OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE CATHETER INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: 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. AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # :(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 AND THE PHYSICIAN TRIED TO IRRIGATE THE CATHETER BY CONNECTING THE PRESSURE BAG; HOWEVER, SALINE DID NOT COME OUT AT THE END OF THE CATHETER. THEY INCREASED THE PRESSURE, AND THIS DID NOT RESOLVE THE ISSUE. THE PHYSICIAN TRIED AGAIN WITH A SYRINGE, AND IT DID NOT IRRIGATE. AFTER REPLACING THE CATHETER, THE ISSUE WAS RESOLVED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE WAS NOTED WHEN THE DEVICE WAS INSERTED INTO THE PATIENT¿S BODY (ABOUT 10 MINUTES). THE PHYSICIAN TOOK OUT THE DEVICE FOR ABLATION AND NOTED THAT IT WAS NOT IRRIGATED. THERE WAS NO ELECTRIC PUMP THAT WAS CONNECTED TO THE PENTARAY CATHETER. IT WAS ONLY THE MANUAL SALINE PRESSER BAG THAT WAS CONNECTED. WHEN THE PHYSICIAN CHECKED THE CATHETER TO PUT IT BACK INTO THE BODY AFTER ABLATION, IT WAS CONFIRMED THAT IT DID NOT IRRIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133139 PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31192918L 10846835012224

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MANUAL SALINE PRESSURE BAG