MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK-1 TRANSSEPTAL NEEDLE, 98 CM LENGTH; TROCAR

Model Number	407207
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During a pulmonary vein isolation procedure, an effusion occurred.Following transseptal puncture, an effusion was suspected.Two echocardiograms were performed and a small effusion on the posterior wall was confirmed.The physician decided to continue with the procedure.During post left atrial mapping, the patient's arterial line pressure dropped down to 45/40.Another echo was performed and revealed the effusion had become moderate.A drain was placed in the epicardial sac and a final echo revealed the effusion had decreased and was no longer growing.The drain was removed and the patient went to the icu.The physician suspected the transseptal needle as causal device.There were no performance issues with the abbott product.
Additional Manufacturer Narrative
Additional information: d9, g6, h2, h3, h6.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.

• Brand Name: BRK-1 TRANSSEPTAL NEEDLE, 98 CM LENGTH
• Common Device Name: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL; 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: 11977363
• Report Number: 3008452825-2021-00335
• Device Sequence Number: 1153378
• Product Code: DRC
• UDI-Device Identifier: 05414734205177
• UDI-Public: 05414734205177
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K072278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: 02/29/2024
• Device Model Number: 407207
• Device Catalogue Number: 407207
• Device Lot Number: 7877103
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 06/25/2021
• 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: 76 YR
• Patient Weight: 98