MAUDE Adverse Event Report: MPRI 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 Code	Nerve Damage (1979)
Date of Event	01/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the data files were returned and analyzed.The data files showed at least 11 applications were performed with balloon catheter 2af284 with lot number 00258 without any issue on the date of the event.A clinical issue (phrenic nerve palsy (pnp)) was encountered during procedure.In conclusion, the reported adverse event could not be confirmed via data analysis.The case was aborted under general anesthesia.There is no indication of relation of adverse event to the performance and malfunction of the product.The physical product was not returned for investigation.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 patient experienced phrenic nerve palsy (pnp).The case was aborted with patient under general anesthesia.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Correction: b5, d3 if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the patient was later discharged from the the hospital and was asymptomatic.

• Brand Name: ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER
• Common Device Name: PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 9708848
• Report Number: 3002648230-2020-00093
• Device Sequence Number: 3350993
• Product Code: OAE
• UDI-Device Identifier: 00643169878365
• UDI-Public: 00643169878365
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/05/2020

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: 10/21/2020
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 00258
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 03/05/2020
• 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; Other
• Patient Age: 68 YR
• Patient Weight: 90