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

Model Number	9-TDS-08F45-80
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
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 that on (b)(6) 2025, an 8f amplatzer talisman delivery sheath was chosen for a procedure.During sheath insertion, it was noted that the tip of the sheath was rolled back and could not be inserted into the blood vessel.The tip of the sheath was reportedly crushed and kink was noted.A new 8f amplatzer talisman delivery sheath was chosen and completed the procedure.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported discharged.
Additional Manufacturer Narrative
It was reported that during sheath insertion the tip of the sheath was rolled back and could not be inserted into the blood vessel.The tip of the sheath was reportedly crushed and kink was noted.A returned device assessment could not be performed as the device was not returned for analysis.No images of the device/issue was provided for review.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There were no related 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: 22748771
• Report Number: 2135147-2025-04383
• Device Sequence Number: 20982151
• Product Code: DQY
• UDI-Device Identifier: 05415067033352
• UDI-Public: (01)05415067033352(17)261130(10)10110257
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/15/2025

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-08F45-80
• Device Catalogue Number: 9-TDS-08F45-80
• Device Lot Number: 10110257
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2023
• 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 Age: 38 YR
• Patient Sex: Male