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

Model Number	2AF284
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); No Code Available (3191)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: flexcath advance steerable sheath.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a cryo ablation procedure, the mapping catheter extended out and punctured the lower lobe of the patient's right lung, which began to fill up with blood.The case was aborted with the patient under general anesthesia.Blood was backed up into the endotracheal tube.A bronchoscopy was performed to remove the blood from the patient's lung.It was noted the right inferior pulmonary vein (ripv) was possibly perforated as well.The patient's hospitalization was extended.The patient was stable at the time of the report, but their recovery time was unknown.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the data files and balloon catheter 2af284 with lot number 14114, were returned and analyzed.The data files showed that at least ten applications were performed with balloon catheter, 2af284 with lot number 14114, without any issue on the date of the event.Visual inspection of the balloon catheter showed the mapping catheter was inserted into the catheter and it was intact with no apparent issues.Smart chip verification indicated the catheter was used for 10 injections.The catheter passed the performance test and electrical integrity as per specification.Clinical issues were encountered during the case.In conclusion, the clinical issues were unable to be confirmed via data analysis or product analysis.The balloon catheter passed the returned product inspection as per specification.There is no indication of relation of adverse event to the performance and malfunction of the product.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Incoming information indicates the patient recovered.

• Brand Name: ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER
• Common Device Name: 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: 9427483
• Report Number: 3002648230-2019-00822
• Device Sequence Number: 2596923
• Product Code: OAE
• UDI-Device Identifier: 00643169976382
• UDI-Public: 00643169976382
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P100010/S015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2020
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 14114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR