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

Model Number G407209

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Cardiac Perforation (2513)

Event Date 05/06/2019

Event Type  Death  

Manufacturer Narrative

Investigation results will be provided in the final report.

Event Description

Related manufacturer reference: 3005334138-2019-00272.During a left-sided accessory pathway ablation, a subaortic valve puncture occurred.During transseptal access, the sheath and needle were introduced and identified at the fossa ovalis with slight tenting of the intraatrial septum into the left atrium demonstrated.Physical adjustment of the ice catheter was made as the image was lost.The next image displayed on the ice machine was of the sl1 sheath anterior and below the level of the aortic valve.The physician then aspirated blood from the stopcock of the brk and injected blood back through the needle and micro bubbles were seen in the aorta on the ice image.A tee image also confirmed this event.The patient was intubated by anesthesia and surgery was performed to remove the sl1 sheath.The patient was not able to be removed from bypass and expired.No product was alleged as the cause of death and there were no performance issues with any abbott device.

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 puncture and subsequent death could not be conclusively determined.

• Brand Name: BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Type of Device: 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, COSTA RICA LTDA (AFD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8637571
• MDR Text Key: 145976960
• Report Number: 3008452825-2019-00245
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205184
• UDI-Public: 05414734205184
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: G407209
• Device Lot Number: 6915245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Weight: 60