MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE DELIVERY SYSTEM; CATHETER, PERCUTANEOUS

Model Number	9-ITV07F180/80
Medical Device Problem Codes	Device Damaged by Another Device (2915); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not returning for evaluation.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) 2025, a 7f amplatzer torqvue delivery system was selected for use in implant of a 16-14mm amplatzer duct occluder.It was noted during procedure that the tip of the delivery system appeared too tight to accommodate the occluder.The delivery system appeared defective to the user.The user had inserted and advanced the occluder into the 7f amplatzer torqvue delivery system with high friction noted during advancement.This resulted damage within the delivery sheath and deformation of the tip of the delivery sheath.There was no damage to the occluder.The decision was made to replace the 7f amplatzer torqvue delivery system with a 8fr amplatzer torqvue delivery system to complete the procedure successfully implanting the same 16-14mm amplatzer duct occluder.The procedure was prolonged under general anesthesia.The patient had no clinical signs or symptoms during or after this event.The patient was in stable condition at the time of report.
Additional Manufacturer Narrative
It was reported that advancement difficulty through delivery system, material deformation and device damaged by another device noted during procedure.A returned device inspection, to rule out any device-related causes could not be performed as the device was not returned for analysis.However, two pictures were provided from the field one picture showing the damage to the tip of the sheath, and another picture showing the occluder advance through the delivery system.Information from the field indicated that the occluder was inserted and advanced into the 7f amplatzer torqvue delivery system with high friction noted during advancement, which resulted damage within the delivery sheath and deformation of the tip of the delivery sheath.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 information received, the cause of the reported incident could not be conclusively determined.However, it is consistent damage during use.There were no complaints associated with any other devices from the lot.There were no adverse effects to the patient and the patient status was reported as stable.There is no indication of a product quality issue with respect to the labeling design or manufacturing of the device.
Additional Manufacturer Narrative
It was reported that advancement difficulty through delivery system, material deformation and device damaged by another device noted during procedure.A returned device inspection, to rule out any device-related causes could not be performed as the device was not returned for analysis.However, two pictures were provided from the field one picture showing the damage to the tip of the sheath, and another picture showing the occluder advance through the delivery system.Information from the field indicated that the occluder was inserted and advanced into the 7f amplatzer torqvue delivery system with high friction noted during advancement, which resulted damage within the delivery sheath and deformation of the tip of the delivery sheath.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 information received, the cause of the reported incident could not be conclusively determined.However, it is consistent damage during use.There were no complaints associated with any other devices from the lot.There were no adverse effects to the patient and the patient status was reported as stable.There is no indication of a product quality issue with respect to the labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2025, a 7f amplatzer torqvue delivery system was selected for use in implant of a 16-14mm amplatzer duct occluder.It was noted during procedure that the tip of the delivery system appeared too tight to accommodate the occluder.The delivery system appeared defective to the user.The user had inserted and advanced the occluder into the 7f amplatzer torqvue delivery system with high friction noted during advancement.This resulted damage within the delivery sheath and deformation of the tip of the delivery sheath.There was no damage to the occluder.The decision was made to replace the 7f amplatzer torqvue delivery system with a 8fr amplatzer torqvue delivery system to complete the procedure successfully implanting the same 16-14mm amplatzer duct occluder.The procedure was prolonged under general anesthesia.The patient had no clinical signs or symptoms during or after this event.The patient was in stable condition at the time of report.No additional information was provided.--final emdr-- subsequent to the previously filed report, additional information was received that the delivery cable was deformed along with the 16-14mm amplatzer duct occluder, but the occluder was normally reshaped and had no damage noted.The defected tip of the 7f amplatzer torqvue delivery system was cause by excessive forced used attempting the advance the occluder.No additional information was provided.

• 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 ; 6517565400
• MDR Report Key: 22544261
• Report Number: 2135147-2025-03949
• Device Sequence Number: 8468318
• Product Code: DQY
• UDI-Device Identifier: 00811806010793
• UDI-Public: (01)00811806010793(17)270731(10)10483103
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• 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): 12/11/2025

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: 10483103
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 11/27/2025; 11/27/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 12/11/2025; 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2024
• 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 Sex: Unknown