BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEZOR XTRA CARDIAC CRYOABLATION CATHETER

    MDR report key: 18937459 · Received March 19, 2024

    Report

    Report Number
    3002648230-2024-00095
    Event Type
    Injury
    Date Received
    March 19, 2024
    Date of Event
    January 1, 2023
    Report Date
    March 19, 2024
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    LPB
    PMA / PMN Number
    P020045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS FEMALE/49 YEARS OLD. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: MINIMAL FLUOROSCOPIC CATHETER ABLATION FOR ADULT PATIENTS WITH PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA WITHOUT THE ASSISTANCE OF INTRACARDIAC ECHOCARDIOGRAPHY. ACTA CARDIOLOGICA SINICA. 2023; 39:546-560. DOI: 10.6515/ACS.202307_39(4).20230111A. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING CATHETER ABLATION FOR PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT). THE AUTHORS DESCRIBED ONE ABLATION PROCEDURE FAILURE; THE PATIENT EXPERIENCED JUNCTIONAL TACHYCARDIA DURING THE ENERGY APPLICATION. THE PROCEDURE WAS ENDED DUE TO IMPAIRED ATRIOVENTRICULAR NODE FUNCTION. THERE WERE TWO PATIENTS WITH COMPLICATIONS FROM THE PROCEDURE. ONE PATIENT DEVELOPED SUSTAINED ATRIOVENTRICULAR BLOCK. THE INITIAL 2:1 ATRIOVENTRICULAR BLOCK, WITH A RIGHT BUNDLE BRANCH BLOCK PATTERN, EVOLVED INTO A COMPLETE ATRIOVENTRICULAR BLOCK. A TEMPORARY PACEMAKER WAS INSERTED INITIALLY, BUT THEN CHANGED TO A PERMANENT PACEMAKER AFTER NO RESOLUTION FROM THE AV BLOCK AFTER TWENTY-FOUR HOURS. ANOTHER PATIENT EXPERIENCED A PUNCTURE SITE HEMATOMA WHICH WAS RESOLVED BY MANUAL COMPRESSION. THE STATUS OF THE CATHETERS IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411102 FREEZOR XTRA CARDIAC CRYOABLATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB MEDTRONIC CRYOCATH LP 227F3

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention