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 Gas/Air Leak (2946); Material Integrity Problem (2978)

Patient Problems Embolism (1829); Paralysis (1997)

Event Date 12/17/2019

Event Type  Injury  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The files showed at least twelve applications were performed with catheter afapro28 with lot number 28147 on the event date.The flow rate and the pressure are within specification.There were three applications without ablation.Clinical issues (paralysis, anorexia, embolism) were encountered post procedure.In conclusion, there is no indication of a malfunction of the balloon catheter related to the adverse event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that following a successful cryoablation procedure which was touched up with radiofrequency, the day after the procedure, the patient's right hand did not move and they developed anorexia.A magnetic resonance imaging (mri) showed embolus-like silhouettes and air ingress was alleged.The patient's symptoms recovered.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 28147 was returned and analyzed.Visual inspection showed that the catheter was intact with no apparent issues.The smart chip verification indicates that the catheter has been used for 12 applications on the date of event.The catheter passed the electrical continuity test.Pin-to-pin impedance measurement did not show any fluctuation.Transition and ablation phase didn't show any temperature artifacts.Temperature profile is as expected.Clinical issues (paralysis, anorexia, emboli) were encountered post procedure.There is no indication of a malfunction of the balloon catheter related to the adverse event.In conclusion, the reported air ingress was not confirmed through testing.The balloon catheter passed the returned product inspection as per specification.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 9591385
• MDR Text Key: 175056473
• Report Number: 3002648230-2020-00036
• 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,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2020
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 28147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4FC12 SHEATH; 4FC12 SHEATH
• Patient Outcome(s): Life Threatening; Other