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

Catalog Number	9-ATV09F45/80
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
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 trevisio intravascular delivery system for a patent foramen ovale (pfo) closure.The delivery system was prepared per instructions for use (ifu).The occluder was attached to the delivery cable.The delivery sheath and dilator were inserted across the pfo.The wire and dilator were removed.The device was about to be flushed when it was noted that the blue stopcock lever was out of the stopcock.The luer was quickly exchanged for a 3-way stopcock.The device was flushed with 60cc of sterile saline to ensure that the device was air free prior to wet to wet connection.No air was seen in the device or in the patient.The remainder of the case was performed successfully without incident.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient status was 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 a blue stopcock lever was out of the stopcock.The device was returned to abbott for analysis.The investigation found that the blue handle knob of the stopcock was noted to not be fully in placed.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 the reported incident could not conclusively be determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
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 trevisio intravascular delivery system for a patent foramen ovale (pfo) closure.The delivery system was prepared per instructions for use (ifu).The occluder was attached to the delivery cable.The delivery sheath and dilator were inserted across the pfo.The wire and dilator were removed.The device was about to be flushed when it was noted that the blue stopcock lever was out of the stopcock.The luer was quickly exchanged for a 3-way stopcock.The device was flushed with 60cc of sterile saline to ensure that the device was air free prior to wet-to-wet connection.No air was seen in the device or in the patient.The remainder of the case was performed successfully without incident.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient status was stable.

• Brand Name: AMPLATZER TREVISIO INTRAVASCULAR 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: 19394249
• Report Number: 2135147-2024-02388
• Device Sequence Number: 12705731
• Product Code: DQY
• UDI-Device Identifier: 05415067030931
• UDI-Public: (01)05415067030931(17)251231(10)8856815
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: 12/31/2025
• Device Catalogue Number: 9-ATV09F45/80
• Device Lot Number: 8856815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• 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: 33 YR
• Patient Sex: Unknown