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

Model Number	9-TDS-09F45-80
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); Non specific EKG/ECG Changes (1817)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2026, a 25-18mm amplatzer talisman pfo occluder was chosen for implant using a 9f talisman delivery system.During the procedure, a brief st-elevation was observed on the ekg, and air was noted on the transesophageal echocardiogram (tee), as reported by the physician.The physician confirmed that this finding represented an air embolism, and the air was visualized in the left atrium.The event occurred after the guidewire and dilator were removed, at which point air became visible.The physician noted that the patient breathed at that moment, prior to connecting the loader, and this sequence of events preceded establishment of the wet-to-wet connection between the sheath and the loader.Following this occurrence, the ekg returned to normal.No medical intervention or medication was administered to treat the air embolus.The patient was under conscious sedation at the time of the event.Additionally, no leak was noted in the delivery system, no air was observed in the device during preparation or the procedure, and the amplatzer talisman pfo occluder was never retracted prior to deployment.There was no allegation of malfunction against the abbott device or the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
An event of air/gas in device, nonspecific ekg changes, and air embolism 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 air/gas in device could not be determined.The reported non-specific ekg changes and air embolism were likely cascading effects from the event; however, this cannot be determined.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.Codes removed: medical device problem code: 2993.
Event or Problem Description
It was reported that on (b)(6) 2026, a 25-18mm amplatzer talisman pfo occluder was chosen for implant using a 9f talisman delivery system.During the procedure, a brief st-elevation was observed on the ekg, and air was noted on the transesophageal echocardiogram (tee), as reported by the physician.The physician confirmed that this finding represented an air embolism, and the air was visualized in the left atrium.The event occurred after the guidewire and dilator were removed, at which point air became visible.The physician noted that the patient breathed at that moment, prior to connecting the loader, and this sequence of events preceded establishment of the wet-to-wet connection between the sheath and the loader.Following this occurrence, the ekg returned to normal.No medical intervention or medication was administered to treat the air embolus.The patient was under conscious sedation at the time of the event.Additionally, no leak was noted in the delivery system, no air was observed in the device during preparation or the procedure, and the amplatzer talisman pfo occluder was never retracted prior to deployment.There was no allegation of malfunction against the abbott device or 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: 24422797
• Report Number: 2135147-2026-01112
• Device Sequence Number: 14965475
• Product Code: DQY
• UDI-Device Identifier: 05415067033369
• UDI-Public: (01)05415067033369(17)270630(10)10451297
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K212738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 03/26/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-TDS-09F45-80
• Device Catalogue Number: 9-TDS-09F45-80
• Device Lot Number: 10451297
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2024
• 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
• Patient Sex: Unknown