MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE 45X45 DELIVERY SHEATH; CATHETER, PERCUTANEOUS

Model Number	9-TV45X45-12F-080
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
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, a 12f amplatzer torqvue sheath was chosen for a procedure.During the procedure, it was observed that the device shavings were visible on the echocardiography, after the device was changed.No additional information was provided.
Additional Manufacturer Narrative
An event of a scratched material (skived inner lining) and improper or incorrect procedure or method 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 scratched material is likely related to the improper or incorrect procedure or method, however this cannot be determined.The reported improper or incorrect procedure or method is related to the delivery sheath not being exchanged after the amulet plug was retracted and removed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: medical device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: 1562.
Event or Problem Description
It was reported that on (b)(6) 2025, a 12f amplatzer torqvue sheath was chosen for a procedure.The delivery system was inspected prior to use, and the device was prepared according to the instructions for use.During the procedure, after the device was changed, it was observed that shavings from the inner plastic lining of the sheath were visible on the echocardiography images.This issue was identified at the end of the case.No intervention was performed after the shavings were noted.The patient remained hemodynamically stable throughout the procedure, and no clinically significant delay occurred.

• Brand Name: AMPLATZER TORQVUE 45X45 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: 23981024
• Report Number: 2135147-2026-00125
• Device Sequence Number: 19991161
• Product Code: DQY
• UDI-Device Identifier: 05415067025883
• UDI-Public: (01)05415067025883(17)270831(10)10510145
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K163000
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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-TV45X45-12F-080
• Device Catalogue Number: 9-TV45X45-12F-080
• Device Lot Number: 10510145
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2024
• 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: Male