BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    MDR report key: 19323220 · Received May 15, 2024

    Report

    Report Number
    2029046-2024-01586
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    April 19, 2024
    Report Date
    June 26, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835023015
    PMA / PMN Number
    K211438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 16-MAY-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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY. THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY LUMEN BECAME OCCLUDED DURING USE IN THE PATIENT, THOUGH IT WAS BEING IRRIGATED WITH HEPARINIZED SALINE AT A KVO RATE. THEY REMOVED THE CATHETER, ATTEMPTED TO FLUSH IT MANUALLY BUT IT WAS COMPLETELY OCCLUDED. THEY EXCHANGED THE CATHETER TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE EVALUATION WAS COMPLETED 31-MAY-2024. THE PRODUCT 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. THE IRRIGATION TEST WAS PERFORMED AND IT WAS NOT FLUSHING CORRECTLY SINCE THE IRRIGATION TUBE WAS BENT INSIDE THE HANDLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE IRRIGATION ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED DUE TO THE BENT IRRIGATION TUBE FOUND INSIDE THE HANDLE. THE POTENTIAL CAUSE OF THE BENT IRRIGATION TUBE COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTION FOR USE (IFU) CONTAINS THE FOLLOWING WARNING AND PRECAUTIONS: PRIOR TO INSERTING THE CATHETER INTO THE BODY, FLUSH THE CATHETER WITH HEPARINIZED NORMAL SALINE. ALWAYS FOLLOW STANDARD PRACTICES OF USING A CONTINUOUS DRIP OF ANTICOAGULANT FLUID UNDER PRESSURE THROUGH THE IRRIGATION LUER WHEN THE CATHETER 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 REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND IT BECAME OCCLUDED DURING USE IN THE PATIENT. THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY LUMEN BECAME OCCLUDED DURING USE IN THE PATIENT, THOUGH IT WAS BEING IRRIGATED WITH HEPARINIZED SALINE AT A KVO RATE. THEY REMOVED THE CATHETER, ATTEMPTED TO FLUSH IT MANUALLY BUT IT WAS COMPLETELY OCCLUDED. THEY EXCHANGED THE CATHETER TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE SUSPECTED DEVICE FOR THE REPORTED ISSUE WAS THE CATHETER. ISSUE WAS DISCOVERED WITH FLUSHING THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY USING A SYRINGE PRIOR TO CONNECTING TO A PUMP. NO ERROR ON THE PUMP. THEY REPLACED THE CATHETER WITH NO ISSUE. THEY DID NOT UTILIZE THE GENERATOR AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490030 OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31070517M 10846835023015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown