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

Model Number	9-TV45X45-14F-080
Medical Device Problem Codes	Retraction Problem (1536); Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
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 (b)(6) 2025, a 14f amplatzer torqvue sheath was chosen for a procedure.During the procedure, the physician was unable to recapture a 31mm amulet device through the 14f sheath for device removal.After multiple unsuccessful attempts, the physician utilized ballooning of the catheter tip to facilitate recapture of the device into the delivery sheath.The delivery catheter had previously been used for two device resizing attempts.The physician was informed that, per the instructions for use (ifu), the delivery system should be replaced with each full recapture and exchange of the device.Despite this, the same catheter was used.During device preparation, was there no issue retracting device into the delivery system.Post-procedure assessment revealed the catheter was kinked in two locations.The physician noted that the patient¿s tortuous anatomy may have contributed to the issue.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
An event of a improper or incorrect procedure or method, retraction problem, and material bent was reported.Imaging was provided from the field showing multiple materials bends on the delivery sheath.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 reported improper or incorrect procedure or method is related to multiple cardiac plugs used on the same delivery sheath.The reported retraction problem likely resulted from the improper or incorrect procedure or method, however this cannot be determined.The reported material bent could have resulted from tortuous anatomy and/or procedural circumstances, however this cannot be determined.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.

• 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: 23967817
• Report Number: 2135147-2026-00084
• Device Sequence Number: 14684634
• Product Code: DQY
• UDI-Device Identifier: 05415067025906
• UDI-Public: (01)05415067025906(17)280630(10)10929862
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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-TV45X45-14F-080
• Device Catalogue Number: 9-TV45X45-14F-080
• Device Lot Number: 10929862
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2025
• 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
• Patient Age: 68 YR
• Patient Sex: Female