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 Code	ST Segment Depression (2487)
Date of Event	01/15/2018
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, the patient experienced a "drop in st level".Coronary angiography (cag) indicated that there was no stenosis, but the contrast media did not flow normally.Nitroglycerin was then administered with resolve.It was noted that the st depression recovered.The case was completed with cryo.Hospitalization was not extended as a result of the event.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 event were returned and analyzed.The files showed at least eleven applications were performed with the electrophysiology catheter, 239f3 lot 94209, without issue.No physical product was returned for analysis.No product malfunction was alleged; a known clinical issue was encountered during the procedure.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: 7245636
• Report Number: 3002648230-2018-00074
• Device Sequence Number: 19093591
• 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
• Report Date (Section B): 03/08/2018

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: 07/12/2019
• Device Model Number: 239F3
• Device Catalogue Number: 239F3
• Device Lot Number: 94209
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 03/08/2018
• 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: Required Intervention
• Patient Age: 67 YR