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

Model Number	239F5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059); Low Cardiac Output (2501); Atrial Perforation (2511); Pericardial Effusion (3271)
Date of Event	11/14/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cryoablation procedure, the patient experienced st elevation.Five minutes later, st elevation depressed.It was further reported that the right coronary artery was slightly spastic.Iv medication was administered and the case was continued.The patient¿s blood pressure fell, hypokinesia was noted during treatment, and an echocardiogram revealed anomalous pericardial effusion.Pericardiocentesis was performed.The physician was suspicious of perforation of the left atrium.The case was completed with cryo.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the data files for the date of the reported event were returned and analyzed.The electrophysiology (ep) catheter, 239f5 with lot 09654, was used for thirteen applications without issue.The ep catheter was not returned for investigation.The reported issues of st levels increasing, a spastic right coronary artery, and possible perforation of the left atrium cannot be confirmed through data analysis.In conclusion, there was no indication of product malfunction and no product to be returned.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
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, quebec H9H 5 H3; CA H9H 5H3
• MDR Report Key: 6153639
• Report Number: 3002648230-2016-00511
• Device Sequence Number: 10977215
• Product Code: OAE
• UDI-Device Identifier: 00643169504899
• UDI-Public: 00643169504899
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100010
• 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,Followup,Followup
• Report Date (Section B): 12/14/2017

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: 02/03/2018
• Device Model Number: 239F5
• Device Catalogue Number: 239F5
• Device Lot Number: 09654
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2016
• Supplement Date Received by Manufacturer: 11/14/2016; 11/14/2016; 11/14/2016; 12/14/2017
• Initial Report FDA Received Date: 12/07/2016
• Supplement Report FDA Received Date: 07/28/2017; 09/27/2017; 12/06/2017; 12/14/2017
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR