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

Model Number	9-TDS-09F45-80
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); Non specific EKG/ECG Changes (1817); Tachycardia (2095)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 30-25mm amplatzer patent foramen ovale (pfo) occluder was successfully implanted in patient using a 9f amplatzer talisman delivery system.The patient was placed under conscious sedation for procedure.It's noted that a wet-to-wet connection from the loader to the delivery system was established when the patient was coughing.There was no continuous flush attached and the dilator or guidewire were removed too quickly or slowly.Post-implant, it was noted via electrocardiogram that the patient developed and st elevation and tachycardia.It's suspected that there was presence of an air embolism.A right heart catheterization was performed to check.Thereafter, a head computed tomography scan was performed and revealed a bit of air on the right side.There was no leak in observed in the 9f amplatzer talisman delivery system.The decision was made to place an arterial line and care to the patient accordingly.The patient did not have any other clinical signs or symptoms during or after this event.The patient eventually stabilized.The patient was stable and recovering but being continuously monitored at the time of report.The patient's snoring and coughing are believe to have contributed to the air embolism.
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
An event of st elevation, tachycardia and air embolism observed during the implant procedure 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 specifications.Based on the information received, the root cause of the reported st elevations, nonspecific ekg/ecg changes in the device results in air embolism could not be conclusively determined.It is believed that extreme snoring with air entrainment contributed to the air embolus/st elevation, tachycardia; however, this cannot be confirmed.The reported unexpected medical intervention was a resulted of case-specific circumstances.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
N/a.

• 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: 22403779
• Report Number: 2135147-2025-03665
• Device Sequence Number: 21255998
• Product Code: DQY
• UDI-Device Identifier: 05415067033369
• UDI-Public: (01)05415067033369(17)280229(10)10776217
• 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: 2025
• 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): 09/16/2025

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: 10776217
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 07/04/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2025
• 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; Hospitalization
• Patient Sex: Unknown