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

Model Number	9-TDS-08F45-80
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2025, a 25-18mm amplatzer talisman pfo occluder was selected for implant using a 8f amplatzer talisman delivery system (ds).During the procedure, the delivery sheath was positioned in the right upper pulmonary vein.While the physician was attempting to unsheath the left disc, when the ds crossed back to the right atrium.After recapturing the device, the physician pulled the device back through the sheath and into the device loader.St elevation was noted at this time signaling an air ingress.The patient was put on 5l o2 via nasal cannula and was complaining of chest pressure.The physician proceeded to re-cross the pfo and resume the procedure.The st elevation subsided after approximately 3 minutes.The patient remained stable for the duration of the procedure.Physician did not state any complaint, allegation, or fault with the device or the delivery system.He suspects that there was reduced blood flow/bleed back in the sheath exchange position of the right upper pulmonary vein and that is what contributed to the air ingress.He states there was adequate bleed back during the wet-to-wet connection of the device and delivery sheath.The device was properly prepped and there was no suspicion of air in the device.The patient is stable.
Event or Problem Description
It was reported that on (b)(6) 2025, a 25-18mm amplatzer talisman pfo occluder was selected for implant using a 8f amplatzer talisman delivery system (ds).During the procedure, the delivery sheath was positioned in the right upper pulmonary vein.While the physician was attempting to unsheath the left disc, when the ds crossed back to the right atrium.After recapturing the device, the physician pulled the device back through the sheath and into the device loader.St elevation was noted at this time signaling an air ingress.The patient was put on 5l o2 via nasal cannula and was complaining of chest pressure.The physician proceeded to re-cross the pfo and resume the procedure.The st elevation subsided after approximately 3 minutes.The patient remained stable for the duration of the procedure.Physician did not state any complaint, allegation, or fault with the device or the delivery system.He suspects that there was reduced blood flow/bleed back in the sheath exchange position of the right upper pulmonary vein and that is what contributed to the air ingress.He states there was adequate bleed back during the wet-to-wet connection of the device and delivery sheath.The device was properly prepped and there was no suspicion of air in the device.The patient is stable.
Additional Manufacturer Narrative
It was reported that during procedure the delivery sheath was positioned in the right upper pulmonary vein, while attempting to un-sheath the left disc the delivery system crossed back to the right atrium.St elevation was noted signaling an air ingress, st elevation subsided after approximately 3 minutes.A returned device inspection, to rule out any device-related causes, 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.Information from field indicated that the physician suspected that there was reduced blood flow/bleed back in the sheath exchange position of the right upper pulmonary vein which contributed to the air ingress.Based on the information received, the cause of the reported air ingress could not be conclusively determined.It is possible that procedural condition (reduced blood flow/bleed back) could have contributed to air ingress.However, this cannot be confirmed.There was unexpected medical intervention reported as the patient was put on 5l o2 via nasal cannula.The patient was reported to be stable for the duration of the procedure.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.

• 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: 22115702
• Report Number: 2135147-2025-02873
• Device Sequence Number: 11824888
• Product Code: DQY
• UDI-Device Identifier: 05415067033352
• UDI-Public: (01)05415067033352(17)270630(10)10432094
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/13/2025

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-08F45-80
• Device Catalogue Number: 9-TDS-08F45-80
• Device Lot Number: 10432094
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female