MAUDE Adverse Event Report: ST. JUDE MEDICAL FIRMAP¿ CATHETER 50MM, US EDM; ELECTRODE RECORDING CATHETER

Model Number	AR064050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	06/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During an atrial fibrillation ablation, a cardiac effusion occurred.The patient became hypotensive and an intracardiac ultrasound was used to visualize the pericardium.A minimal amount of pericardial effusion was noted but no intervention or further treatment was administered.Despite the blood pressure normalizing, the procedure was cancelled.The patient was stabilized.
Additional Manufacturer Narrative
One firmap¿ catheter 50mm, us edm was received for investigation.No visual anomalies were noted with the returned device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event pericardial effusion is unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: FIRMAP¿ CATHETER 50MM, US EDM
• Common Device Name: ELECTRODE RECORDING CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8778864
• Report Number: 3005334138-2019-00366
• Device Sequence Number: 16669858
• Product Code: MTD
• UDI-Device Identifier: 00810591020017
• UDI-Public: 00810591020017
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K163709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

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: 11/30/2020
• Device Model Number: AR064050
• Device Catalogue Number: AR064050
• Device Lot Number: TPR110117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 09/25/2019
• 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: Other
• Patient Age: 57 YR