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

Model Number	9-ITV08F45/80
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
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 that on (b)(6) 2026, an 8f amplatzer torqvue delivery system was chosen for a procedure.During device preparation, specifically during the exhaust process, it was observed that the delivery system had split open and was unable to expel air.It was further clarified that the delivery system did not come into contact with the patient, and the occluder also did not come into contact with the patient.Due to significant leakage discovered during the exhaust process, a new 8f amplatzer torqvue delivery system was used as a replacement device was used to complete the procedure.The patient has now recovered.
Additional Manufacturer Narrative
An event of a fluid leak 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 fluid leak could not be determined.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.Codes removed: medical device problem code: 4008.
Event or Problem Description
It was reported that on (b)(6) 2026, an 8f amplatzer torqvue delivery system was chosen for a procedure.After opening the package, the delivery system was inspected, and the device was prepared according to the instructions for use (ifu).During device preparation, specifically during the exhaust process (performed prior to any patient contact), it was observed that the delivery system was unable to expel air due to leakage.Following confirmation with the customer, the issue was clarified as leakage originating from the three-way valve.It was further reported that the leakage occurred during the exhaust process and involved physiological saline, with leaking from the three-way valve during this step.The delivery system did not come into contact with the patient, and the occluder also did not come into contact with the patient.The procedure was completed using a new 8f amplatzer torqvue delivery system.The patient has since recovered.

• 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: 24254098
• Report Number: 2135147-2026-00604
• Device Sequence Number: 8346267
• Product Code: DQY
• UDI-Device Identifier: 00811806010847
• UDI-Public: (01)00811806010847(17)280331(10)10800832
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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-ITV08F45/80
• Device Catalogue Number: 9-ITV08F45/80
• Device Lot Number: 10800832
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 80 KG