MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA 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	10/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
Related manufacturer reference number: 3008452825-2020-00585; 3005334138-2020-00530; 3005334138-2020-00531; 3008452825-2020-00583.During the procedure, a pericardial effusion was observed.After completing left atrial geometry and voltage mapping and doing an inferior posterior wall radiofrequency ablation line at 45 watts and 40 degrees, the access sheath was pulled to the right atrium, and the superior vena cava was ablated at 25 watts.The patient became hypotensive, and intracardiac echocardiography was used to check for an effusion with trans-thoracic echocardiography confirming a pericardial effusion.A pericardiocentesis was performed.The patient was stable upon leaving the lab.
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-1 TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Common Device Name: TROCAR
• 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: 10738641
• Report Number: 3008452825-2020-00584
• Device Sequence Number: 16973523
• Product Code: DRC
• UDI-Device Identifier: 05414734205160
• UDI-Public: 05414734205160
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 11/12/2020

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: 7547867
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 11/12/2020
• 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: ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿; AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿; FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿; TACTICATH¿ CONTACT FORCE CATHETER, SENSOR ENABLED¿; ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿; AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿; FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿; TACTICATH¿ CONTACT FORCE CATHETER, SENSOR ENABLED¿
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 69 YR