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

Catalog Number	9-ITV09F45/80
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, a 25mm amplatzer pfo occluder was chosen for implant with a 9f amplatzer torqvue delivery system.The patient was under local anesthesia.During procedure, the occluder was loaded into the delivery system and the delivery system was introduced to the patient and delivered into the left upper pulmonary vein.The inner core was withdrawn and connected to the loader immediately after removal of the dilator at normal speed when it was noted air bubbles were visualized in the blood flow in the delivery system.A decision was made to use a syringe to continuously discharge the bubbles.It was reported that constant aspiration was being performed on the valve side hole.A continuous saline flush was attached to the loader.It was reported all the connectors were tightly connected but air leakage was found in the delivery system.After removal of air bubbles, the delivery system was removed from the patient and replaced with a second 9f amplatzer torqvue delivery system.It was reported the 25mm occluder was successfully implanted with the replacement delivery system.The patient status was reported as stable and there was no report of any adverse patient consequences.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of air/gas in device was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The device was returned to abbott for investigation and it was examination and performed functional testing.There was no leaks or air was noted during the returned analysis.Based on information available, the cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 18257855
• Report Number: 2135147-2023-05321
• Device Sequence Number: 15371752
• Product Code: DQY
• UDI-Device Identifier: 00811806010861
• UDI-Public: 00811806010861
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

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 Expiration Date: 04/30/2025
• Device Catalogue Number: 9-ITV09F45/80
• Device Lot Number: 8496014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2022
• 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: 32 YR
• Patient Sex: Female
• Patient Weight: 44 KG