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

Model Number	9-TDS-09F45-80
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
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 one (b)(6) 2025, a 25-18mm amplatzer talisman patent foramen ovale (pfo) occluder was selected for implant using a 9f amplatzer talisman delivery sheath.It was noted during procedure when tightening of component of the delivery sheath, that the dilator broke during loosening and prior to removal of the dilator and wire.At the time of the break, the component being tightened was the connector between the dilator and the delivery sheath.The decision was made to remove the 9f amplatzer talisman delivery sheath and replace it with another one of the same size to complete the procedure.There was no clinically significant delay in the procedure, and the patient did not experience any clinical signs or symptoms during or after the event.Additionally, no leak was observed in the 9f amplatzer talisman delivery sheath.The patient was stable the time of report.
Additional Manufacturer Narrative
An event of delivery sheath hub fracture during procedure was reported.The device was returned to abbott for investigation and was found to confirm the reported fracture at the hub.The delivery sheath was noted to be kinked, which is likely due to packaging for return.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 available information, the cause of the reported event could not be conclusively determined.However, the reported hub fracture was may be due to excessive force/manipulation on the delivery system but cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 22570875
• Report Number: 2135147-2025-04022
• Device Sequence Number: 4021561
• Product Code: DQY
• UDI-Device Identifier: 05415067033369
• UDI-Public: (01)05415067033369(17)280131(10)10715759
• 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): 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-TDS-09F45-80
• Device Catalogue Number: 9-TDS-09F45-80
• Device Lot Number: 10715759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 25-18MM AMPLATZER TALISMAN (PFO) OCCLUDER
• Patient Sex: Unknown