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

Model Number	9-PDA-004
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 6-4mm amplatzer duct occluder was selected for implant using a 6f amplatzer torqvue delivery system (ds).There were no issues noted during device prep.During the procedure, there was no difficulty traversing the hub; however, the inner diameter of the sheath was noted to be extremely tight making it difficult to advance the occluder.The ds was replaced with a second 6f amplatzer torqvue ds, but the same issue occurred.This resulted in deformity of the amplatzer duct occluder (b/l# 10362650).After much effort, the device eventually exited the sheath and was positioned correctly.The patient remained hemodynamically stable throughout the procedure.There were no adverse consequences, but the procedure prolonged and there was the possibility of shearing microplastics into the patient.The patient is stable.
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
It was reported that the inner diameter of the sheath was noted to be extremely tight making it difficult to advance the occluder resulting in device deformity.A returned device inspection, to rule out any device-related causes could not be performed as the device was not returned for analysis.The correct size delivery system was used and no damage to the delivery system was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2025, a 6-4mm amplatzer duct occluder was selected for implant using a 6f amplatzer torqvue delivery system (ds).There were no issues noted during device prep.During the procedure, there was no difficulty traversing the hub, however the inner diameter of the sheath was noted to be extremely tight making it difficult to advance the occluder.The ds was replaced with a second 6f amplatzer torqvue ds, but the same issue occurred.This resulted in deformity of the amplatzer duct occluder (b/l# 10362650).After much effort, the device eventually exited the sheath and was positioned correctly.The patient remained hemodynamically stable throughout the procedure.There were no adverse consequences, but the procedure prolonged and there was the possibility of shearing microplastics into the patient.The patient is stable.

• 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: 21538264
• Report Number: 2135147-2025-01137
• Device Sequence Number: 7071299
• Product Code: MAE
• UDI-Device Identifier: 00811806011110
• UDI-Public: (01)00811806011110(17)290531(10)10362650
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P020024
• 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): 04/04/2025

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 Model Number: 9-PDA-004
• Device Catalogue Number: 9-PDA-004
• Device Lot Number: 10362650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2024
• 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: 12 MO
• Patient Sex: Male