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

Model Number	9-ITV07F180/80
Medical Device Problem Codes	Difficult to Insert (1316); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 8-6mm amplatzer pda occluder was chosen for implant using an unknown delivery system.During the procedure, it was reported that the device was not able to be retrieved back to the sheath.No additional information provided.
Event or Problem Description
It was reported that on 11 may 2025, an 10-8mm amplatzer pda occluder was chosen for implant using a 7f amplatzer torqvue delivery system.It was reported that the device could not be retracted back into the sheath during an attempt to retrieve it for size exchange.No patient complications or adverse events were reported during or after the procedure, and the patient experienced no clinical signs or symptoms.The patient remained hemodynamically stable throughout the procedure, with no clinically significant delay reported, and was stable and discharged post-procedure.
Additional Manufacturer Narrative
An event of a loader to sheath handoff failure and recapture the occluder device was reported.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.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.Based on the available information, the cause for the reported loader to sheath handoff failure could not be determined.It is possible that procedural circumstances (insufficient tightening) contributed to the event, 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 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: 25432165
• Report Number: 2135147-2026-03858
• Device Sequence Number: 10310557
• Product Code: DQY
• UDI-Device Identifier: 00811806010793
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-ITV07F180/80
• Device Catalogue Number: 9-ITV07F180/80
• Device Lot Number: 10885987
• Was Device Available for Evaluation?: No
• 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: 05/14/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2025
• 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