BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 13258725 · Received January 14, 2022

    Report

    Report Number
    3002648230-2022-00023
    Event Type
    Injury
    Date Received
    January 14, 2022
    Date of Event
    May 24, 2021
    Report Date
    January 14, 2022
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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/65 YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. 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: THE LONG-TERM EFFECT OF THERMAL-GUIDED SECOND-GENERATION CRYOABLATION IN PAROXYSMAL AND PERSISTENT ATRIAL FIBRILLATION. INDIAN PACING AND ELECTROPHYSIOLOGY JOURNAL 21 (2021) 261-266. DOI.ORG/10.1016/J.IPEJ.2021.05.002. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING CRYOABLATION. THE ARTICLE REPORTS PATIENTS WHO UNDERWENT CRYOBALLOON ABLATION AND EXPERIENCED PERICARDIAL EFFUSION REQUIRING PERICARDIOCENTESIS, TRANSIENT ISCHEMIC ATTACK (TIA) OR STROKE, PSEUDOA ANEURYSM OF THE SUPERFICIAL FEMORAL ARTERY, WHICH REQUIRED THROMBIN INJECTION, AORTIC ROOT PERFORATION, AND HEMATOMA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE STATUS/DISPOSITION OF THE SHEATHS AND CATHETERS IS UNKNOWN. FURTHER FOLLOW UP DID NOT YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627144 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention