BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 19144661 · Received April 19, 2024

    Report

    Report Number
    3002648230-2024-00157
    Event Type
    Death
    Date Received
    April 19, 2024
    Date of Event
    December 15, 2023
    Report Date
    April 19, 2024
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 MALE/62 YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. THE DATE OF DEATH IS NOT AVAILABLE AT THE TIME OF THIS REPORT AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. 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: ASSOCIATION OF TYPICAL ATRIAL FLUTTER AND CAVOTRICUSPID ISTHMUS ABLATION ON CLINICAL RECURRENCE AFTER CRYOBALLOON ABLATION FOR ATRIAL FIBRILLATION. FRONTIERS IN CARDIOVASCULAR MEDICINE. 2023. 10:1303635. DOI: 10.3389/FCVM.2023.1303635. 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 CRYOBALLOON ABLATION. THE AUTHORS DESCRIBED ONE PATIENT DEATH; HOWEVER, THE CAUSE OF DEATH WAS UNKNOWN. THERE WERE PATIENTS WHO EXPERIENCED ACUTE MYOCARDIAL INFARCTION, STROKE, THE NEED FOR CARDIAC SURGERY, PERICARDIAL EFFUSIONS IN WHICH SOME REQUIRED PERICARDIOCENTESIS, ACCESS SITE COMPLICATIONS WHICH REQUIRED INTERVENTION IN SOME PATIENTS, COMPLETED ATRIOVENTRICULAR (AV) BLOCK, TRANSIENT PHRENIC NERVE INJURY, HEMOPTYSIS, PULMONARY VEIN STENOSIS, AND GASTROPARESIS. THE STATUS OF THE CATHETERS AND SHEATHS IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082426 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Death