MAUDE Adverse Event Report: Abbott Medical Amplatzer Torqvue 45x45 Delivery Sheath; Catheter, Percutaneous

Model Number	9-TV45X45-14F-080
Medical Device Problem Codes	Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a 14f amplatzer amulet delivery sheath was chosen for a procedure.The patient was reported to have tortuous anatomy, which made advancement of the delivery sheath and dilator difficult.Prior to the procedure, the delivery sheath was inspected for damage, kinks, or obstructions.The device was properly flushed and prepared according to the ifu before attempting delivery.During removal of the sheath and dilator, a tear was observed in the dilator.As a result, the delivery system was replaced with a new 14f amplatzer amulet delivery sheath (lot: 11347613).Upon use of a second delivery system, a similar issue was encountered.The physician subsequently removed the system to further dilate the vascular access site.During removal, it was noted that the guidewire had split the second torqvue delivery system.Later, a third delivery system which is a 14f amplatzer amulet delivery sheath (lot: 11347613) was successfully used to complete the procedure.The physician reported that the issue was not with the delivery system, but rather the patient's difficult anatomy.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects reported.
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.

• 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 ; +1(651)756-5400
• MDR Report Key: 50819077
• Report Number: 2135147-2026-06307
• Device Sequence Number: 10218710
• Product Code: DQY
• UDI-Device Identifier: 05415067025906
• UDI-Public: (01)05415067025906(17)281130(10)11183670
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 11183670
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2025
• 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 Sex: Unknown