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

Model Number	G407212
Health Effect - Clinical Codes	Cardiac Perforation (2513); Vascular Dissection (3160)
Date of Event	06/18/2020
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 manufacturing ref: 3008452825-2020-00321, 3008452825-2020-00322.During a persistent atrial fibrillation ablation procedure, a cardiac tamponade and dissection occurred.Difficulty was noted during catheterization of the vein of marshall and a coronary sinus dissection occurred.When applying the 4th rf application on the mitral isthmus, the patient¿s blood pressure collapsed and an echocardiogram revealed a cardiac tamponade.A pericardiocentesis was performed, however the patient was unstable.There were no performance issues with any abbott devices.
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 remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.
Additional Manufacturer Narrative
Correction: h6 health impact code.Additional information: h6 component code.

• Brand Name: BRK-1 XS TRANSSEPTAL NEEDLE, 98 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: 10190081
• Report Number: 3008452825-2020-00323
• Device Sequence Number: 13689913
• Product Code: DRC
• UDI-Device Identifier: 05414734205191
• UDI-Public: 05414734205191
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2021

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: 07/31/2022
• Device Model Number: G407212
• Device Catalogue Number: G407212
• Device Lot Number: 7125278
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 07/06/2020; 07/15/2021
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/15/2020; 07/21/2021
• 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: AGILIS¿ NXT STEERABLE INTRODUCER; TACTICATH¿ ABLATION CATHETER, SE
• Outcome Attributed to Adverse Event: Required Intervention