MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK-1 TRANSSEPTAL NEEDLE, 71 CM LENGTH; TROCAR

Model Number	407201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	10/05/2020
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
Related manufacturer ref: 3005334138-2020-00484.During an atrial fibrillation ablation procedure, during either the transseptal puncture or during initial mapping, a cardiac perforation occurred.After the transseptal puncture was performed under intracardiac echocardiography with a non-abbott guidewire through a brk needle and introduced, the catheter was introduced into the left atrium.While creating the geometry, a pericardial effusion was noted on intracardiac echocardiography in the dome of the left atrium and the procedure was cancelled.The patient was noted to be hypotensive.The patient went into surgery where a pericardiocentesis was performed, vasopressors and blood transfusions were given, and thoracic surgical intervention was conducted to repair the tear in the dome of the left atrium.The patient was noted to be in a stable condition.There were no performance issues with any abbott products.
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 cardiac perforation could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: BRK-1 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
• MDR Report Key: 10779828
• Report Number: 3008452825-2020-00539
• Device Sequence Number: 19114261
• Product Code: DRC
• UDI-Device Identifier: 05414734205160
• UDI-Public: (01)05414734205160(10)7540401(17)230531
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/11/2020

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: 05/31/2023
• Device Model Number: 407201
• Device Catalogue Number: 407201
• Device Lot Number: 7540401
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SWARTZ TRANSSEPTAL GUIDING INTRODUCER; SWARTZ TRANSSEPTAL GUIDING INTRODUCER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Weight: 70