BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    MDR report key: 18907308 · Received March 14, 2024

    Report

    Report Number
    2029046-2024-00838
    Event Type
    Malfunction
    Date Received
    March 14, 2024
    Date of Event
    February 20, 2024
    Report Date
    March 14, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012248
    PMA / PMN Number
    K123837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA RIGHT (R-AT) PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND A CLOT ISSUE OCCURRED. THE PHYSICIAN MADE A RIGHT ATRIAL MAP WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. WHEN HE WAS FINISHED USING THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND WAS GOING TO PULL IT OUT OF THE RIGHT ATRIUM, HE SAW VIA THE ULTRASOUND IMAGE OF HIS ACUNAV INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER THAT THERE WERE CLOTS ON THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. HE PROCEEDED TO PULL THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER OUT OF THE BODY AND IT WAS NOT NEEDED FOR THE REMAINDER OF THE CASE. NO MEDICAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THE CLOTS ON THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WERE DUE TO NORMAL SALINE BEING USED FOR THE CONTINUOUS PRESSURE DRIP INSTEAD OF HEPARINIZED SALINE, WHICH WAS A MISTAKE IN COMMUNICATING WITH THE STAFF. THE PHYSICIAN INITIALLY THOUGHT THAT MAYBE THE PATIENT ALREADY HAD CLOTS IN THEIR INFERIOR VENA CAVA (IVC) BECAUSE IT WAS DIFFICULT TO MANEUVER THE CATHETER FROM THE START OF THE CASE. HOWEVER, WHEN DISCUSSING AFTERWARDS WITH THE PHYSICIAN, THE PROBLEM WAS MOST LIKELY DUE TO A LACK OF ANTICOAGULATION OF THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. THIS WAS DISCUSSED WITH THE STAFF AND THE PHYSICIAN AFTER THE CASE TO PREVENT THE ISSUE FROM HAPPENING IN THE FUTURE. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. ADDITIONAL INFORMATION WAS RECEIVED. THE CLOT WAS LOCATED ON THE SPLINES OF THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. NO ERROR MESSAGES ON THE SYSTEM. THE PHYSICIAN SAID THAT IT FELT DIFFICULT TO MANEUVER THE CATHETER. HE THOUGHT MAYBE THE PATIENT HAD SOME CLOTS IN THEIR IVC. THERE WERE NO ISSUES RELATED TO FLOW ON THE CATHETER. THEY DID NOT HAVE THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER IN THE BODY DURING THE ABLATION PORTION OF THE CASE. THEY WERE IN THE RIGHT ATRIUM, SO THE PATIENT WAS NOT ANTICOAGULATED. ON THE LEFT SIDE, THE PHYSICIAN ALWAYS FOLLOWS STANDARD ANTICOAGULATION PRACTICES AND CHECKS THE ACT EVERY 15 MINUTES. UNAWARE IF THE PATIENT EXHIBITED ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. THE PHYSICIAN CONSIDERS THAT THE CLOT WAS EXCESSIVE (BASED ON THEIR CLINICAL EXPERIENCE). SINCE THE PHYSICIAN SAW THE CLOT ON ULTRASOUND AND REMOVED THE CATHETER, HE DID NOT COMMENT ON THE AMOUNT OF RISK IT COULD CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162113 PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 10846835012248

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female ACUNAV (ICE) CATHETER