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

Model Number	9-TDS-09F45-80
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Atrial Flutter (1730); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported on (b)(6) 2025 a 30-25mm amplatzer talisman pfo occluder using a 9f amplatzer talisman delivery sheath to treat a patent foramen ovale (pfo).The patient presented with challenging anatomy with an extremely mobile interatrial septum.Transseptal access was anterior in front of the pfo tunnel.The patient's activated clotting time (act) level was 250 seconds.During the procedure it was noted that the occluder was too small to adequately cover the pfo tunnel.The occluder was removed from the patient and replaced with a 35-25mm amplatzer talisman pfo occluder.The guidewire was advanced slightly anterior to the pfo opening into the left atrium.During deployment of the right atrial disc the delivery sheath was positioned somewhat in the aortic orientation.Due to the septal mobility and recurrent episodes of atrial flutter, the occluder could not be positioned optimally within the pfo tunnel.The procedure was aborted.Later the same day the patient developed a cardiac tamponade.A pericardiocentesis was performed.The patient status was stable.The user believed the delivery sheath irritated the left atrial wall due to the patient's septal mobility and atrial flutter.
Additional Manufacturer Narrative
An event of positioning problem with health effects of pericardial effusion, cardiac tamponade, and atrial flutter 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.There were no complaints associated with any other devices from the lot.Based on the available information, the cause for the reported positioning problem with health effects of pericardial effusion, cardiac tamponade, and atrial flutter could not be confirmed.An unexpected medical intervention was a result of case-specific circumstances, a pericardiocentesis was performed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported on (b)(6) 2025 a 30-25mm amplatzer talisman pfo occluder using a 9f amplatzer talisman delivery sheath to treat a patent foramen ovale (pfo).The patient presented with challenging anatomy with an extremely mobile interatrial septum.Transseptal access was anterior in front of the pfo tunnel.The patient's activated clotting time (act) level was 250 seconds.During the procedure it was noted that the occluder was too small to adequately cover the pfo tunnel.The occluder was removed from the patient and replaced with a 35-25mm amplatzer talisman pfo occluder.The guidewire was advanced slightly anterior to the pfo opening into the left atrium.During deployment of the right atrial disc the delivery sheath was positioned somewhat in the aortic orientation.Due to the septal mobility and recurrent episodes of atrial flutter, the occluder could not be positioned optimally within the pfo tunnel.The procedure was aborted.Later the same day the patient developed a cardiac tamponade.A pericardiocentesis was performed.The patient status was stable.The user believed the delivery sheath irritated the left atrial wall due to the patient's septal mobility and atrial flutter.

• 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: 23085552
• Report Number: 2135147-2025-05253
• Device Sequence Number: 9848714
• Product Code: DQY
• UDI-Device Identifier: 05415067033369
• UDI-Public: (01)05415067033369(17)280229(10)10784508
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 12/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 10784508
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2025
• 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: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female