MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA (AFD) BRK-1 XS TRANSSEPTAL NEEDLE, 71 CM LENGTH; TROCAR

Model Number G407209

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

Patient Problem Air Embolism (1697)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

During a pulmonary vein isolation procedure, after two transseptal punctures were made and catheters and introducers were inserted into the heart, a transient change of the heart rhythm morphology involving st segment elevation was seen for a few minutes.The ecg went back to normal on its own, and the procedure went well.There were no adverse patient consequences and there was no allegation of malfunction against any abbott device.The physician believed the st elevation was caused by a transient air embolus.No specific exam was performed to confirm the occurrence of an air embolus.

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.

• Brand Name: BRK-1 XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Type of Device: TROCAR
• Manufacturer (Section D): 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
• MDR Report Key: 10646537
• MDR Text Key: 210373430
• Report Number: 3008452825-2020-00542
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205184
• UDI-Public: 05414734205184
• Combination Product (y/n): N
• PMA/PMN Number: K122587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: G407209
• Device Catalogue Number: G407209
• Device Lot Number: 7534155
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 10/07/2020
• Supplement Dates FDA Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other