MAUDE Adverse Event Report: ABBOTT MEDICAL Amplatzer Torqvue Delivery System; Catheter, Percutaneous

Model Number	9-ITV06F180/80
Medical Device Problem Codes	Difficult to Insert (1316); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported on 19 august 2025 a 6f amplatzer torqvue delivery system was selected for a procedure.During the procedure while attempting to insert the delivery system into the easter access point the delivery system was stuck and could not be advanced.The release mechanism was able to be inserted, however the sheath could not.Several attempts were made to insert the delivery sheath but were unsuccessful.While changing the delivery sheath, contrast angiography was performed on the access site revealing a dissection of the right femoral vein.The procedure was aborted in order to treat the vein dissection.The dissection was compressed until the dispersion of flow in the angiogram was no longer observed.The patient status was stable.The user believed the delivery system caused the dissection.
Additional Manufacturer Narrative
An event of delivery system was stuck near access point during procedure was reported.A returned device inspection, to rule out any device-related causes, could not be performed as the delivery system 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 specifications.There were no complaints associated with any other devices from the lot.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.
Event or Problem Description
It was reported on (b)(6) 2025 a 6f amplatzer torqvue delivery system was selected for a procedure to treat a patent ductus arteriosus (pda).During the procedure while attempting to insert the delivery system into the access point the delivery system was stuck and could not be advanced.The release mechanism was able to be inserted, however the sheath could not.Several attempts were made to insert the delivery sheath but were unsuccessful.While changing the delivery sheath, contrast angiography was performed on the access site revealing a dissection of the right femoral vein.The procedure was aborted in order to treat the vein dissection.The dissection was inflated with a balloon until the dispersion of flow in the angiogram was no longer observed.The patient status was stable.The user believed the delivery system caused the dissection.

• Brand Name: Amplatzer Torqvue Delivery System
• 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: 23075736
• Report Number: 2135147-2025-05240
• Device Sequence Number: 9719445
• Product Code: DQY
• UDI-Device Identifier: 00811806010779
• UDI-Public: (01)00811806010779(17)271130(10)10653673
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K072313
• 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,Followup
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-ITV06F180/80
• Device Catalogue Number: 9-ITV06F180/80
• Device Lot Number: 10653673
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/27/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 11/17/2025; 09/16/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 11/20/2025; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown