MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH; TROCAR

Model Number	G407208
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	08/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturing reference: 3008452825-2023-00360.During a ventricular tachycardia procedure, a small pericardial effusion occurred.No intervention was required but the procedure was cancelled.The patient remained stable but was monitored overnight in the intensive care unit.The first transseptal puncture was unsuccessful due to rotated heart.Puncture was believed to be in pericardium as evidenced by no left atrial pressure noted.Transesophageal echocardiogram guidance was used for second puncture attempt and the brk xs was exchanged for brk 1.During echo, it was noted that there was a small effusion.The physician decided to continue the procedure at this time as the effusion was small and stable and the patient was asymptomatic.Second transeptal puncture was attempted but was unsuccessful which was evidence by aortic pressures.The procedure was abandoned, and the effusion was stable.The physician believes the effusion most likely occurred during the first transeptal puncture which was in the pericardium.However, he abandoned the case after the second transeptal puncture which was in the aorta.There were no performance issues with any abbott device.
Additional Manufacturer Narrative
Additional information: d9, g1, g3, 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¿ XS TRANSSEPTAL NEEDLE, 71 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
• Manufacturer (Section G): 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
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17568574
• Report Number: 3008452825-2023-00359
• Device Sequence Number: 12433404
• Product Code: DRC
• UDI-Device Identifier: 05414734205139
• UDI-Public: 05414734205139
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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: 01/31/2026
• Device Model Number: G407208
• Device Lot Number: 8904558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown