BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    MDR report key: 21621736 · Received March 17, 2025

    Report

    Report Number
    2029046-2025-00802
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. NOTE: FOR FIELD D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND AN INFUSION ALARM SOUNDED. DURING PRE-MAPPING, AN ALARM FOR INFUSION PUMP BLOCKAGE SOUNDED. ALTHOUGH THE CATHETER WAS PULLED FROM THE PATIENT'S BODY, STRAIGHTENED, AND INFUSED AGAIN OUTSIDE THE PATIENT'S BODY AND TRANSFUSED AGAIN, BUT THE ALARM DID NOT STOP. DEVICE INVESTIGATION DETAILS: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED 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 OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND AN INFUSION ALARM SOUNDED. DURING PRE-MAPPING, AN ALARM FOR INFUSION PUMP BLOCKAGE SOUNDED. ALTHOUGH THE CATHETER WAS PULLED FROM THE PATIENT'S BODY, STRAIGHTENED, AND INFUSED AGAIN OUTSIDE THE PATIENT'S BODY AND TRANSFUSED AGAIN, BUT THE ALARM DID NOT STOP. THE ISSUE WAS ADDRESSED BY REPLACING THE CATHETER WITH A NEW OPTRELL BUT THE ALERT OCCURRED AT THE TIME OF FLUSHING BEFORE INSERTING THE CATHETER INTO THE PATIENT'S BODY. SINCE PERFUSION WAS ACHIEVED, CONTINUED USE WAS PERMITTED WITH THE PHYSICIAN'S APPROVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565730 OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NGEN PUMP, JAPAN CONFIGURATION| UNK_OPTRELL MAPPING CATHETER