MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FREEZOR MAX CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	239F3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	05/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following a completed cryo ablation procedure using an electrophysiology (ep) catheter and a competitor catheter, the patient¿s blood pressure declined and a pericardial effusion was confirmed.Drainage was performed.It was further reported that the patients condition was ¿good¿.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the data files were not related to the date of the event.The electrophysiology catheter was not returned for investigation.There was no indication of product malfunction.A known clinical issue was encountered during the procedure (pericardial effusion and hypotension).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information reported that the patient's hospital stay was extended and the patient was discharged without any issues.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: FREEZOR MAX 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: 6630209
• Report Number: 3002648230-2017-00267
• Device Sequence Number: 16414463
• Product Code: OAE
• UDI-Device Identifier: 00643169504905
• UDI-Public: 00643169504905
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2017

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: 09/01/2017
• Device Model Number: 239F3
• Device Catalogue Number: 239F3
• Device Lot Number: 92410
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2017
• Supplement Date Received by Manufacturer: 06/19/2017; 06/19/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 07/12/2017; 10/05/2017
• 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; Required Intervention