BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    MDR report key: 18528321 · Received January 17, 2024

    Report

    Report Number
    2029046-2024-00199
    Event Type
    Injury
    Date Received
    January 17, 2024
    Date of Event
    December 19, 2023
    Report Date
    January 22, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835025828
    PMA / PMN Number
    K230253
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 INVESTIGATION WAS COMPLETED ON 19-JAN-2024. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31114169M AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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 AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND SUFFERED AN ARTERY DISSECTION. IT WAS REPORTED THAT AFTER MAPPING WITH THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND TRYING TO SWITCH TO AN ABLATION CATHETER, THE ACCESS THEY HAD THROUGH THE FEMORAL ARTERY, WAS NO LONGER AVAILABLE. THERE MAY BE SOME SORT OF DISSECTION OF THE ARTERIAL VESSEL. THE CASE WAS ABORTED BY THE PHYSICIAN. THE ABLATION CATHETER WAS NEVER IN THE PATIENT AND THE ONLY CATHETER USED WAS THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY. ADDITIONAL INFORMATION WAS RECEIVED. A SHORT 9F SHEATH WAS USED FOR FEMORAL VEIN/ARTERY ACCESS. INTERVENTION WAS PRESSURE TO RESOLVE HEMATOMA AND MINIMIZE BLEEDING. FOLLOWED BY CT ANGIOGRAM TO EVALUATE EXTENT OF DAMAGE. PHYSICIAN AND FELLOW BELIEVE IT WAS DUE TO PATIENT ANATOMY AND PRE-EXISTING CONDITION. POTENTIALLY DUE TO MANIPULATION OF CATHETERS. IT WAS BELIEVED THAT THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION BUT THEN BEING SENT HOME. THE LAST UPDATE OF THE OUTCOME OF THE ADVERSE EVENT WAS NO LONG TERM CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511057 OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31114169M 10846835025828

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other