BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 19621102 · Received June 26, 2024

    Report

    Report Number
    3002648230-2024-00279
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    May 12, 2024
    Report Date
    June 26, 2024
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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/59 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. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: SEX-BASED DIFFERENCES AND RISK OF RECURRENCE IN PATIENTS WITH ATRIAL FIBRILLATION UNDERGOING PULMONARY VEIN ISOLATION. INTERNATIONAL JOURNAL OF CARDIOLOGY. 2024. 409; 132161. DOI: 10.1016/J.IJCARD.2024.132161 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 SEX DIFFERENCES IN PATIENTS UNDERGOING CATHETER ABLATION. THE AUTHORS DESCRIBED PATIENTS WHO UNDERWENT CRYOABLATION AND EXPERIENCED SEVERE ACCESS SITE BLEEDING, PHRENIC NERVE INJURY, GAS EMBOLISM, HIGH-GRADE ATRIOVENTRICULAR BLOCK, UPPER AIRWAY BLEEDING, HEMATOMA, VENOUS THROMBOSIS, ARTERIOVENOUS FISTULA, FEMORAL PSEUDOANEURYSM, PERICARDITIS, CARDIAC TAMPONADE, AND PERICARDIAL EFFUSION. ONE PATIENT PRESENTED WITH A PERICARDIAL EFFUSION AT THE END OF THE PROCEDURE FOR WHICH THEY UNDERWENT PERICARDIOCENTESIS; AND LATER DEVELOPED PERICARDITIS. ANOTHER PATIENT SUFFERED A GAS EMBOLISM DURING THE PROCEDURE WITH CONCOMITANT ST SEGMENT ELEVATION, WHICH LED TO PROMPT CORONARY ANGIOGRAPHY; AFTER THE PROCEDURE, THIS PATIENT ALSO SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND LATER DEVELOPED PERICARDITIS AFTER THE TAMPONADE WAS RESOLVED. 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
    2102196 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Life Threatening| R