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	02/24/2026
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 on (b)(6) 2026, a 14 f amplatzer torqvue delivery sheath was chosen for a procedure.The delivery sheath was inspected for damage, kinks, or obstructions prior to use and found acceptable, and it was properly flushed and prepared per the ifu before delivery.The patient¿s anatomy was reported to be tortuous.During advancement of the delivery system over the wire into the femoral access site, the physician was unable to advance the sheath and encountered resistance immediately past the skin.The delivery system had not contacted the guidewire prior to the split tip being noticed (placing over the wire, no damage visualized).After multiple attempts, the physician removed the sheath over the wire and observed that the dilator was damaged, with a small tear at its distal end.The procedure was subsequently completed using a new 14f amplatzer torqvue delivery sheath.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 difficult to advance and split sheath/dilator tip was reported.The device was returned to abbott for investigation, and the dilator and sheath were each visually examined, and a damaged split was noted at the tip of the dilator.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 investigation findings, the dilator tip separation issue appears to be related to a potential product quality issue; therefore, exception (issue) 130010 was initiated on 18 oct 2023 to further investigate this complaint.The primary root cause was related to the potential for the raw material to not homogeneously blend during the melt processing.This potential cause relating to the material characteristics of this material is the root cause of the noted dilator being cut into two pieces.
Event or Problem Description
It was reported that on (b)(6) 2026, a 14 f amplatzer torqvue delivery sheath was chosen for a procedure.The delivery sheath was inspected for damage, kinks, or obstructions prior to use and found acceptable, and it was properly flushed and prepared per the ifu before delivery.The patient¿s anatomy was reported to be tortuous.During advancement of the delivery system over the wire into the femoral access site, the physician was unable to advance the sheath and encountered resistance immediately past the skin.The delivery system had not contacted the guidewire prior to the split tip being noticed (placing over the wire, no damage visualized).After multiple attempts, the physician removed the sheath over the wire and observed that the dilator was damaged, with a small tear at its distal end.The procedure was subsequently completed using a new 14f amplatzer torqvue delivery sheath.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.

• 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: 24651966
• Report Number: 2135147-2026-01787
• Device Sequence Number: 9786268
• Product Code: DQY
• UDI-Device Identifier: 05415067025906
• UDI-Public: (01)05415067025906(17)281031(10)11121290
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 04/27/2026

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: 11121290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2025
• 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: 74 YR
• Patient Sex: Female