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
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The balloon catheter afapro28, with lot 15876, and the data files were returned and analyzed.The data files indicated seven applications were performed with the returned balloon catheter and eight applications were performed with a non-returned balloon catheter.The files indicated that a 50005 system noticed received indicating that the safety system detected fluid in the catheter and stopped the injection, was received using the returned balloon catheter.Visual inspection of the catheter showed the device was intact with no apparent issues.Verification of the smart chip file indicated the catheter was used for seven applications on the day of the event.A 50005 system notice, indicating that the safety system detected fluid in the catheter and stopped the injection appeared during the integrity test.The dissection test showed a kink on the guide wire lumen at 1.2017 inches from the tip of the catheter.The pressure test showed a breach through the kink on the guide wire lumen and an inner balloon burst.Additionally, the kink could cause an unexpected balloon shape.In conclusion, the balloon catheter afapro28, with lot 15876 failed the returned product inspection due to inner balloon burst, the kink and breach on the guide wire lumen.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
After a completed case, the balloon catheter subsequently tested out of specification per the manufacturer's investigation.
Additional Manufacturer Narrative
Product event summary: further testing of the afapro28 balloon catheter with lot 15876 showed through dissection and pressure testing, that the inner balloon had a breach/crack instead of a burst as previously reported.In conclusion, the balloon catheter also failed the returned product inspection due to a balloon breach/crack.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
• 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: 9788796
• Report Number: 3002648230-2020-00139
• Device Sequence Number: 11425593
• Product Code: OAE
• UDI-Device Identifier: 00763000088637
• UDI-Public: 00763000088637
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2020
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 15876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1