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

Model Number G407208

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

Patient Problem Cardiac Perforation (2513)

Event Date 04/02/2019

Event Type  Injury  

Manufacturer Narrative

No product was returned for investigation. the device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott, the reported perforation could not be confirmed.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

Related manufacturer reference: 3005334138-2019-00225.During transseptal puncture for a pvc ablation procedure, a perforation occurred.An x-ray and tee imaging confirmed the perforation, which required no intervention.The patient was asymptomatic and stable.The procedure was not completed.The following day, ct imaging confirmed the aorta was in good condition.There were no alleged performance issues with any abbott device.It was indicated the perforation may have occurred due to the patient anatomy.

• Brand Name: BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Type of Device: TRANSSEPTAL NEEDLE
• 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: 8544375
• MDR Text Key: 142903927
• Report Number: 3008452825-2019-00202
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205139
• UDI-Public: 05414734205139
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2019

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: No Information
• Device Expiration Date: 12/31/2021
• Device Model Number: G407208
• Device Lot Number: 6829379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER
• Patient Outcome(s): Other