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

Catalog Number	9-ATV10F45/80
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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) 2024, a 35mm amplatzer cribriform occluder was selected for implant using a 10f amplatzer trevisio intravascular delivery system.The device was manually attached and turned 1/8 counterclockwise as per ifu during device preparation.The occluder was advanced through the delivery cable "as per normal." the cable connection was not checked prior to deployment.During deployment, the occluder "came off the delivery cable on its own whiles being deployed.It was in the correct position at the time it became detached." therefore, no attempts were made to reconnect the device.The occluder ultimately successfully implanted.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
An event of the occluder came off the delivery cable on its own during procedure was reported.The investigation found no anomalies with the function of the delivery cable.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.It was indicated that the cable connection was not checked prior to deployment.The cause of the reported event could not be conclusively determined, however it is possible the first occluder was not attached securely enough to the cable in the field.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 20495567
• Report Number: 2135147-2024-05209
• Device Sequence Number: 11642736
• Product Code: DQY
• UDI-Device Identifier: 05415067030948
• UDI-Public: (01)05415067030948(17)270430(10)10343261
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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 Catalogue Number: 9-ATV10F45/80
• Device Lot Number: 10343261
• 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: 10/01/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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 Age: 33 YR
• Patient Sex: Female