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

Model Number	9-ATV07F45/80
Medical Device Problem Codes	Retraction Problem (1536); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, a 11mm amplatzer septal occluder (aso) was implanted as usual with use of a 7f amplatzer trevisio delivery system.The physician did not encounter any difficulty or resistance with the device implant.After the aso was implanted in the defect, the delivery cable was detached from the aso without any issue.When the delivery cable was being pulled into the trevisio delivery sheath, resistance was felt.After pulling out from the patient, fibrous form like substances was visually confirmed adhering onto 1-2cm of the tip of the delivery cable.The physician alleged that although the aso was able to be detached from the delivery cable as usual, resistance was felt while the delivery cable was pulled into the delivery sheath.So the polyester fiber might have been accidentally tangled by the cable.At present, no findings have been confirmed under echo observation and fluoroscopy of the aso after placement.The product box containing the delivery system did not appeared damaged in any way.Patient stable, no additional information was provided.
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 resistance being felt while removing the device and a fibrous like substances adhering onto 1-2cm of the tip of the delivery cable was reported.The device was received for analysis which found that a red colored fiber-like material was adherent to the delivery cable.This fiber was sent for analysis and was found to be biological material.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.As the fiber/biological material was found after removal of the device from the patient, it could have come from the patient's body.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: AMPLATZER TREVISIO
• 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: 16421119
• Report Number: 2135147-2023-00634
• Device Sequence Number: 6602687
• Product Code: DQY
• UDI-Device Identifier: 05415067030900
• UDI-Public: 05415067030900
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/04/2023

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: 09/30/2024
• Device Model Number: 9-ATV07F45/80
• Device Catalogue Number: 9-ATV07F45/80
• Device Lot Number: 8198172
• 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: 01/31/2023
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2021
• 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: 9-ATV0745/80/ LOT#: 8198172).
• Patient Age: 10 YR
• Patient Sex: Male