BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEZOR MAX CARDIAC CRYOABLATION CATHETER

    MDR report key: 15894350 · Received December 1, 2022

    Report

    Report Number
    3002648230-2022-00482
    Event Type
    Injury
    Date Received
    December 1, 2022
    Date of Event
    August 25, 2021
    Report Date
    December 1, 2022
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. PATIENT AGE, GENDER, OR WEIGHT CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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 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 WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: SYMPTOMATIC AND ASYMPTOMATIC INTRACEREBRAL HEMORRHAGES DETECTED BY MAGNETIC RESONANCE IMAGING AFTER CATHETER ABLATION OF ATRIAL FIBRILLATION. JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. (2022) 64:443¿454. DOI: 10.1007/S10840-021-01051-6. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 CRYOBALLOON ABLATION. THE ARTICLE REPORTS FOURTEEN PATIENTS WHO DEVELOPED NEW INTRACEREBRAL HEMORRHAGES (ICHS) WITH ACUTE ICH CHARACTERISTICS ON THE INITIAL MAGNETIC RESONANCE IMAGING (MRI) ON THE DAY AFTER THE PROCEDURE OR NEW-ONSET ICH WITH ACUTE, SUBACUTE, OR CHRONIC ICH CHARACTERISTICS ON THE REPEAT MRI THAT WAS UNDETECTABLE ON THE INITIAL MR IMAGING. ONE PATIENT HAD DOUBLE VISION THREE DAYS AFTER THE PROCEDURE, AND A NEW-ONSET HEMORRHAGIC LESION WAS FOUND ON THE REPEAT MRI. THAT SYMPTOM SPONTANEOUSLY RESOLVED IN A FEW DAYS AFTER THE MRI. THE REMAINING PATIENTS HAD ASYMPTOMATIC ICHS. NONE OF THE PATIENTS EXPERIENCED SYMPTOMATIC CEREBROVASCULAR EVENTS DURING THE SUBSEQUENT FOLLOW-UP PERIOD. THE STATUS/DISPOSITION OF THE CATHETERS IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2711399 FREEZOR MAX CARDIAC CRYOABLATION CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 209F3

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other