MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE 2 DS; CATHETER, PERCUTANEOUS

Model Number	9-TV2-06F120
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976); No Apparent Adverse Event (3189); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na it is unknown if the device is returning for analysis.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 mm x 5 mm amplatzer valvular plug iii was chosen for implant using a 6f amplatzer torqvue 2 delivery (tv2) sheath.During procedure, a transeptal puncture in superior mid septum achieved with non-abbott sheath and non-abbott system.The guidewire placed into left upper pulmonary vein (lupv) and non-abbott sheath was removed and another non-abbott sheath was placed.A non-abbott catheter 1 and then 2 and non-abbott glide wire used to cross defect.The defect was long serpiginous tract and a non-abbott guide wire was replaced non- abbott glide.When the physician attempted to pass 6f tv2 sheat sheath through tract.But the physician mentioned the that the tip of the dilator was too soft and was easily deformed.The transitions were not tapered sufficiently to allow sheath to advance.The 6f tv2 sheath was removed and 6f non-abbott sheath was used to pass through defect and 14 mm x 5 mm amplatzer valvular plug iii was implanted.The case time was extended due to "mucking around" with trying to advance tv2.The patient remained hemodynamically stable throughout the procedure.The patient was reported stable.

• Brand Name: AMPLATZER TORQVUE 2 DS
• 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: 24970141
• Report Number: 2135147-2026-02660
• Device Sequence Number: 20081708
• Product Code: DQY
• UDI-Device Identifier: 00811806012513
• UDI-Public: (01)00811806012513(17)261231(10)10148625
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K162228
• 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): 06/18/2026

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-TV2-06F120
• Device Catalogue Number: 9-TV2-06F120
• Device Lot Number: 10148625
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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 Age: 83 YR
• Patient Sex: Female