MAUDE Adverse Event Report: Abbott Medical Amplatzer Talisman Delivery Sheath; Catheter, Percutaneous

Model Number	9-TDS-09F45-80
Medical Device Problem Codes	Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	07/27/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2026, an amplatzer vascular plug ii was chosen for implant using a 9f amplatzer talisman delivery sheath.The device properly flushed and prepared according to the ifu before attempting delivery.Prior to the procedure, the patient was reported to be stable.During the procedure, while attempting to advance the occluder, resistance was encountered and the sheath kinked.No difficulty implanting the device, such as multiple manipulations, was reported.Following the procedure on an unknown date, a pericardial effusion developed.Subsequently, the patient experienced tamponade and died after the operation.The date and cause of death was reported as unknown; however, it was thought to be due to wire perforation and cardiac tamponade.
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.B2: date of death is estimated.

• Brand Name: Amplatzer Talisman Delivery Sheath
• Common Device Name: Catheter, Percutaneous
• Manufacturer (Section D): Abbott Medical; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): Abbott Medical Reg# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50439736
• Report Number: 2135147-2026-05813
• Device Sequence Number: 9186548
• Product Code: DQY
• UDI-Device Identifier: 05415067033369
• UDI-Public: (01)05415067033369(17)280930(10)11099462
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K212738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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 Model Number: 9-TDS-09F45-80
• Device Catalogue Number: 9-TDS-09F45-80
• Device Lot Number: 11099462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 39 YR
• Patient Sex: Female