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	06/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, a 25mm amplatzer pfo occluder was chosen for implant using a 9f amplatzer torqvue delivery system.The patient was under conscious sedation.During procedure, the delivery system was put into the body.After the sheath entered the body, the inner core was withdrawn.The amplatzer pfo occluder was loaded.The outer sheath was connected to the syringe to contain physiological saline.The connectors were all tightly connected.When the syringe was withdrawn, air leakage was found in the sheath.No air was visualized in the patient.The physician believed that the sheath connection was not air tight.The guidewire was exchanged.The delivery system was replaced with another 9f amplatzer torqvue delivery system.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported as stable.
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 leakage was found in the sheath could not be confirmed.The device was returned to abbott, and the delivery cable was inserted through the hemostasis valve and tightened.A syringe was attached to the stopcock, the components were submerged, and then were flushed with water to remove the air.The loader was then connected to the sheath and flushed with water and examined.No bubbles or leaks were found.Then entire delivery system was submerged in water again and flushed with air to check for leaks, and no leaks were found in any connections.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of reported event could not be conclusively 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 ; 6517565400
• MDR Report Key: 19638998
• Report Number: 2135147-2024-03149
• Device Sequence Number: 7093164
• Product Code: DQY
• UDI-Device Identifier: 00811806010861
• UDI-Public: (01)00811806010861(17)260930(10)10017783
• 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): 08/08/2024

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: 09/30/2026
• Device Catalogue Number: 9-ITV09F45/80
• Device Lot Number: 10017783
• 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: 06/06/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER PFO OCCLUDER, 9-PFO-025
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 55 KG