MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER DUCT OCCLUDER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Catalog Number	9-PDA-004
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
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 a 6-4mm amplatzer duct occluder was selected for implant on (b)(6) 2024 using an 6f amplatzer torqvue delivery system.During the procedure there was difficulty advancing the delivery sheath through the patient anatomy.There was also difficulty loading the occluder into the delivery sheath.Excessive force was used to push the occluder into the delivery sheath, causing the disc of the occluder to form an s-shape and the delivery sheath to kink.The occluder was not released from the delivery cable.The occluder and delivery sheath were both removed from the patient and replaced with a new 6-4mm amplatzer duct occluder and 6f amplatzer torqvue delivery system.There were no interactions with cardiac structures.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
An event of difficulty advancing a delivery sheath through the patient anatomy and deformation was reported.Information from the field indicated that excessive force was used to push the occluder into the delivery sheath, causing the disc of the occluder to form an s-shape and the delivery sheath to kink.The field also indicated that there was a kink in the delivery system.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 event of advancement difficulty could not conclusively be determined.However, the reported deformation could have been due to the kinking of the sheath due to the force exerted on the delivery system.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• 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: 20044466
• Report Number: 2135147-2024-04128
• Device Sequence Number: 20822155
• Product Code: MAE
• UDI-Device Identifier: 00811806011110
• UDI-Public: (01)00811806011110(17)280630(10)9163497
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 09/23/2024

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-PDA-004
• Device Lot Number: 9163497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2023
• 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: 6F AMPLATZER TORQVUE DELIVERY SYSTEM
• Patient Sex: Unknown