MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA BRK¿ TRANSSEPTAL NEEDLE, 98 CM LENGTH

Model Number	407206
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	07/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation ablation procedure, a cardiac perforation occurred.Following transseptal access and creation of the left atrial model the patient became hypotensive.Intracardiac echography confirmed a 1cm pericardial effusion.All catheters were removed from the patient and protamine was administered to reverse the blood thinning.A pericardiocentesis was performed to stabilize the patient.The cause of the reported perforation was during transseptal access.There were no performance issues with any abbott device.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: BRK¿ TRANSSEPTAL NEEDLE, 98 CM LENGTH
• Common Device Name: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 7741459
• Report Number: 3008452825-2018-00259
• Device Sequence Number: 19237093
• Product Code: DRC
• UDI-Device Identifier: 05414734205122
• UDI-Public: 05414734205122
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K072278
• 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): 09/06/2018

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: 03/31/2021
• Device Model Number: 407206
• Device Catalogue Number: 407206
• Device Lot Number: 6429389
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 09/06/2018
• 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: 83 YR