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

Model Number	2AF234
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Code Available (3191); Pericardial Effusion (3271)
Date of Event	05/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, a pericardial effusion was observed.A pericardiocentesis was performed and the patients vitals signs remained stable.The case was aborted and the patient was under general anesthesia.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Event summary: the patient data files did show that during multiple injections there was oscillation within the flow and temperature performance with catheter 2af234 / 50663 which was used for nine injections.A clinical issue was encountered during cryo ablation procedure, and a pericardial effusion was noted.The balloon catheter was not returned for analysis.In conclusion, a clinical issue (pericardial effusion) was encountered post procedure.The case was aborted under while the patient was under general anesthesia.There is no indication of catheter malfunction related to the adverse event.There was no product returned for product investigation.If information is provided in the future, a supplemental report will be issued.

• 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: 7554279
• Report Number: 3002648230-2018-00344
• Device Sequence Number: 176957
• Product Code: OAE
• UDI-Device Identifier: 00643169753686
• UDI-Public: 00643169753686
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2018

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: 01/24/2019
• Device Model Number: 2AF234
• Device Catalogue Number: 2AF234
• Device Lot Number: 50663
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4FC12 SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR