MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TALISMAN DELIVERY SHEATH; CATHETER, PERCUTANEOUS

Model Number	9-TDS-09F45-80
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 25-18mm amplatzer talisman pfo occluder was chosen for implant using an 9f amplatzer talisman delivery system.After implantation, it was observed that there was a liver bleed noted in the patient.It was noted that the cause that led to the bleeding was due to difficulty in advancing the ice catheter.Therapeutic heparin was administered, and blood transfusion was required to treat the event.There is no allegation of malfunction against the abbott device or procedure.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
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.
Additional Manufacturer Narrative
There was no reported device malfunction associated with the amplatzer talisman delivery system.An event for patient effects of bleeding was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.After implantation, it was observed that there was a liver bleed noted in the patient.Based on the information received, the cause of the reported bleeding could not be conclusively determined.It is possible due to procedural conditions (difficulty in advancing the ice catheter); however, it cannot be confirmed.The reported unexpected medical intervention was a resulted of case-specific circumstances, as therapeutic heparin was administered, and blood transfusion was required to treat the event.
Event or Problem Description
It was reported that on (b)(6) 2025, a 25-18mm amplatzer talisman pfo occluder was chosen for implant using an 9f amplatzer talisman delivery system.After implantation, it was observed that there was a liver bleed noted in the patient.It was noted that the cause that led to the bleeding was due to difficulty in advancing the ice catheter.Therapeutic heparin was administered, and blood transfusion was required to treat the event.There is no allegation of malfunction against the abbott device or procedure.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.

• 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 ; 6517565400
• MDR Report Key: 24075005
• Report Number: 2135147-2026-00309
• Device Sequence Number: 15731678
• Product Code: DQY
• UDI-Device Identifier: 05415067033369
• UDI-Public: (01)05415067033369(17)280731(10)10991880
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: 10991880
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown