BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 19183489 · Received April 25, 2024

    Report

    Report Number
    3002648230-2024-00175
    Event Type
    Injury
    Date Received
    April 25, 2024
    Date of Event
    April 17, 2023
    Report Date
    April 25, 2024
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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/64 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: THE ABSENCE OF REAL-TIME PULMONARY VEIN ISOLATION DURING CRYOBALLOON ABLATION IS ASSOCIATED WITH ATRIAL FIBRILLATION RECURRENCE AND PULMONARY VEIN RECONNECTION. JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. 2023. 66: 2091¿2101. DOI: 10.1007/S10840-023-01538-4. 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 (CBA) OF ATRIAL FIBRILLATION (AF). THE AUTHORS DESCRIBED THREE PATIENTS WHO EXPERIENCED PERMANENT SEQUELAE POST ABLATION; TWO PATIENTS HAD A PHRENIC NERVE INJURY THAT PERSISTED, AND ONE PATIENT HAD MILD DYSARTHRIA WITH LEFT HEMIPLEGIA DUE TO A STROKE. THERE WERE OTHER PATIENTS WITH UNKNOWN COMPLICATIONS, BUT MOST OF THEM RESOLVED COMPLETELY AFTER TREATMENT. 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
    1605165 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention