MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE 45X45 DELIVERY SHEATH; CATHETER, PERCUTANEOUS

Model Number	9-TV45X45-14F-080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
(b)(6) - veritas, patient site id: (b)(6).It was reported that on (b)(6) 2025, a 25mm amplatzer amulet 2 was chosen for implant.Post-procedure on (b)(6) 2025, a transthoracic echocardiography (tte) noted a left to right residual shunt through the transseptal puncture.No treatment or intervention was required.
Additional Manufacturer Narrative
An event with patient effects of perforation 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.There were no complaints associated with any other devices from the lot.Based on the available information, the cause for the reported patient effects of perforation is related to the procedural circumstances, as transseptal puncture is necessary for the procedure.A serious injury was a result of case-specific circumstances.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
(b)(6) - veritas, patient site id: (b)(6) (b)(4).It was reported that on (b)(6) 2025, a 25mm amplatzer amulet 2 was chosen for implant.Post-procedure on (b)(6) 2025, a transthoracic echocardiography (tte) noted a left to right residual shunt through the transseptal puncture.No treatment or intervention was required.

• 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: 23605860
• Report Number: 2135147-2025-06753
• Device Sequence Number: 9917702
• Product Code: DQY
• UDI-Device Identifier: 05415067025906
• UDI-Public: (01)05415067025906(17)280331(10)10823094
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-TV45X45-14F-080
• Device Catalogue Number: 9-TV45X45-14F-080
• Device Lot Number: 10823094
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 87 KG