BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDTEMP¿

    MDR report key: 23832518 · Received December 17, 2025

    Report

    Report Number
    3015180993-2025-00010
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    October 8, 2025
    Report Date
    December 17, 2025
    Manufacturer
    EPIX THERAPEUTICS
    Product Code
    OAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PULMONARY VEIN ISOLATION ABLATION IT WAS OBSERVED THAT THE CATHETER PERFORATED THE SURFACE OF THE LEFT ATRIUM. A PERICARDIAL EFFUSION OCCURRED, CONFIRMED WITH AN ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED. THE CASE OUTCOME IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2245975 DIAMONDTEMP¿ CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE EPIX THERAPEUTICS EPIX-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R