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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

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MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION Back to Search Results
Model Number 2AF284
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Inflammation (1932); ST Segment Elevation (2059); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: flexcath advance steerable sheath.Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Of note, multiple patients/multiple methods/multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers/methods/manufacturers.The overall baseline gender characteristics is male; the age of the patients was 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.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿midterm outcomes of catheter ablation for atrial fibrillation in patients with cardiac tamponade.¿ journal of arrhythmia.2019; 35:109¿120.Doi: 10.1002/joa3.12127.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The literature publication reported the following patient complications during the use of a cryoballoon ablation catheter system.There were patients who experienced cardiac tamponade.Of note, multiple patients, multiple methods, and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.In one patient, cardiac tamponade occurred immediately after pulmonary vein isolation by cryoballoon and pericardiocentesis was performed; pericarditis occurred two days after catheter ablation and medications were administered.Then the pericarditis resolved, the patient was discharged.However, 33 days after catheter ablation, the patient experienced new-onset shortness of breath and presented to the emergency department.Increased pericardial fluid and inflow blockage was seen on the echo-cardiogram.The patient was diagnosed with ¿recurrent cardiac tamponade¿ and a repeat pericardiocentesis was performed.It was also noted, that st elevation on electrocardiogram (ecg) and increased serum c-reactive protein levels supported the diagnosis of recurrent pericarditis.There was also a patient with cardiac tamponade, which required pericardiocentesis.The status/location of the cryoballoon catheter system is unknown.Further follow up did not yet yield any additional information.No further patient complications have been reported as a result of this event.
 
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Brand Name
ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER
Type of Device
PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
Manufacturer (Section D)
MEDTRONIC CRYOCATH LP
9000 autoroute transcanadienne
pointe-claire,qc H9R 5 Z8
CA  H9R 5Z8
Manufacturer (Section G)
MEDTRONIC CRYOCATH LP
9000 autoroute transcanadienne
pointe-claire,qc H9R 5 Z8
CA   H9R 5Z8
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key9913584
MDR Text Key188328908
Report Number3002648230-2020-00194
Device Sequence Number1
Product Code OAE
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100010/S015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Physician
Type of Report Initial
Report Date 04/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number2AF284
Device Catalogue Number2AF284
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/16/2020
Initial Date FDA Received04/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age64 YR
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