BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    MDR report key: 22092610 · Received May 27, 2025

    Report

    Report Number
    2029046-2025-01709
    Event Type
    Injury
    Date Received
    May 27, 2025
    Date of Event
    April 30, 2025
    Report Date
    May 27, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835025828
    PMA / PMN Number
    K230253
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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 ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND SUFFERED AN ASYSTOLE WHICH REQUIRED PACING AND UNDERWENT BIV ICD IMPLANT. THE REPORT INDICATED THAT WHILE MAPPING THE LEFT VENTRICLE WITH THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY, THE PATIENT BECAME ASYSTOLE. THE HEART WAS PACED WITH A CORONARY SINUS (CS) CATHETER THAT WAS ALREADY IN PLACE. PATIENT IS CURRENTLY UNDERGOING A BIV ICD IMPLANT AND IS STABLE. THE INJURY WAS CONDUCTION SYSTEM ASYSTOLE DISCOVERED ON THE 12 LEAD ECG, AS WELL AS NO HEART MOVEMENT ON FLUOROSCOPY. NO ABLATION CATHETER OPENED YET, A DECAPOLAR CS, OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY IN USE. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THE ISSUE WAS THAT THE AV NODE, HIS, OR PART OF THE CONDUCTION SYSTEM JUST DROPPED OUT DUE TO MYOCARDITIS AND DOES NOT BELIEVE IT WAS A CONSEQUENCE OF MAPPING OR ANY OF THE CATHETERS IN THE HEART. NO ABLATION SYSTEM WAS USED. ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PATIENT RELATED, NOT DEVICE RELATED. THE OUTCOME OF THE ADVERSE EVENT WAS THE PATIENT¿S CONDITION DID NOT IMPROVE AND TRANSFERRED TO ANOTHER FACILITY FOR FURTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714633 OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31310512M 10846835025828

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H| L CARTO 3 SYSTEM| JJMTEP DECAPOLAR CS CATHETER| UNKNOWN X-RAY FLUORO SYSTEM