MAUDE Adverse Event Report: ST. JUDE MEDICAL TRANSSEPTAL NEEDLE, BRK SERIES

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

Patient Problem Cardiac Perforation (2513)

Event Date 06/04/2019

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 effusion/tamponade could not be confirmed.Per the ifu, cardiac perforation is a known risk during the use of this device.Further information regarding the product details were requested but not received.

Event Description

Related manufacturer reference: 2135147-2019-00197, 2135147-2019-00198, 2135147-2019-00199.During an amulet implantation procedure, an effusion occurred.The sheath was kinked when assembling the amulet prosthesis.The sheath was exchanged, however the same issue occurred.Transseptal access was performed again, and the sheath and prosthesis were exchanged with successful implantation.An ultrasound confirmed an effusion/tamponade in the pericardium.A pericardiocentesis was performed to stabilize the patient.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• 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: 8752617
• MDR Text Key: 149773152
• Report Number: 3008452825-2019-00304
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/02/2019

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: AMULET DELIVERY SHEATH (X3)
• Patient Outcome(s): Other