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

Model Number AFAPRO28

Device Problems Device Contamination with Body Fluid (2317); Gas/Air Leak (2946)

Patient Problems Embolism (1829); Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059); Exit Block (2628)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, after inserting the balloon catheter into the sheath the back flow of blood was aspirated from the sideport of the sheath and more air was aspirated than usual.A slight st segment elevation was observed and the procedure was able to continue.Later the occlusion was attempted but unable to be performed and after deflating the balloon, a remarkable st segment elevation was observed and the patient's blood pressure decreased and a transient atrioventricular block developed.Medication was administered and intervention was performed.The case was aborted.A whole body computerized tomography (ct) scan was taken in addition to an magnetic resonance imaging (mri) of the head and no evidence of air was found; however, the physician stated air might have flown into the coronary artery.The patient's hospitalization was extended and they were discharged at a later date.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the balloon catheter afapro28 with lot number 00961 was returned and analyzed.Visual inspection of the catheter showed the device was intact with no apparent issues.Smart chip verification indicated the catheter was used for one injection.The catheter passed the performance test and electrical integrity as per specification; impedance was also within specification.Inflations were sustained for more than 2 minutes.Dissection / pressure testing did not show any leaks along the vacuum line that might have caused the excessive flow or frost.A clinical issue was encountered during the procedure.In conclusion, the clinical issue (st elevation, hypotension, heart block, embolism, and air ingress) could not be confirmed through testing.The reported balloon catheter passed the returned product inspection as per specifications.There is no indication of relation of adverse events to the performance of the cryo device.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.

• Brand Name: ARCTIC FRONT ADVANCE PRO¿ 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
• MDR Report Key: 9899406
• MDR Text Key: 188328210
• Report Number: 3002648230-2020-00186
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/28/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2020
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 00961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 04/06/2020
• Supplement Dates FDA Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4FC12 SHEATH, 2ACH20 MAPPING CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention