BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    MDR report key: 21643581 · Received March 19, 2025

    Report

    Report Number
    2029046-2025-00834
    Event Type
    Injury
    Date Received
    March 19, 2025
    Date of Event
    February 21, 2025
    Report Date
    March 19, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835025828
    PMA / PMN Number
    K230253
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31316207M AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. HOWEVER, IF THE PRODUCT IS 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 ABLATION WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THE PATIENT EXPERIENCED VESSEL PERFORATION THAT DID NOT REQUIRE INTERVENTION. AFTER GOING TRANSSEPTAL AND INSERTING THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY THROUGH THE TRANSSEPTAL SHEATH, THE PHYSICIAN THOUGHT THE CATHETER WAS IN THE LEFT ATRIUM (LA) BUT WAS IN THE AORTA. THEY HAD ¿PERFORATED¿ THE AORTA. THEY TOOK A LOOK USING FLUOROSCOPY, AND THEN INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING, AND NOTICED THE ISSUE. THE OR TEAM CAME IN, THE OPTRELL¿ CATHETER WAS REMOVED FROM THE BODY, AND THE PATIENT WAS MONITORED. THE PATIENT DID NOT SHOW ANY OTHER ISSUES AFTER THAT. MONITORING CONTINUED. THE PATIENT WAS IN STABLE CONDITION AT THAT TIME THE CALLER LEFT THE ROOM. NO ABLATION CATHETER WAS USED SINCE THERE WAS NO ABLATION YET COMPLETED ON THE PATIENT AT THE TIME THE INCIDENT HAPPENED. ADDITIONAL INFORMATION WAS RECEIVED. NO INTERVENTION WAS NEEDED. THE PHYSICIAN DID NOT THINK THERE WAS A BIOSENSE WEBSTER, INC. PRODUCT MALFUNCTION. THE PHYSICIAN STATED THAT IT WAS A DIFFICULT TRANSSEPTAL. ONE TRANSSEPTAL PUNCTURE SITE WAS PERFORMED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493388 OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31316207M 10846835025828

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Life Threatening CARTO 3 SYSTEM| UNK SHEATH| UNK_NGEN RF GENERATOR