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

Model Number	9-PDAP-05-06-L
Medical Device Problem Codes	Malposition of Device (2616); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that (b)(6) 2025, a 5 mm x 6 mm amplatzer piccolo occluder was chosen for a patent ductus arteriosus (pda) closure procedure using a 4f amplatzer torqvue low profile catheter.During procedure, when using the product, it was deployed in an extended form against the target pda.The device was removed and a new 5 mm x 4 mm amplatzer piccolo occluder was chosen and completed the procedure.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported stable.
Event or Problem Description
It was reported that on (b)(6) 2025, a 5 mm x 6 mm amplatzer piccolo occluder was chosen for a patent ductus arteriosus (pda) closure procedure using a 4f amplatzer torque low profile catheter.During procedure, when using the product, it was deployed in an extended form against the target pda.The device was removed prior to release from the delivery cable while inside the patient and a new 5 mm x 4 mm amplatzer piccolo occluder was chosen and completed the procedure.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported stable.
Additional Manufacturer Narrative
There was no issues noted on the occluder.Please see (b)(6) for the reported event related to the delivery system.

• Brand Name: AMPLATZER PICCOLO
• 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: 22123543
• Report Number: 2135147-2025-02903
• Device Sequence Number: 8669602
• Product Code: MAE
• UDI-Device Identifier: 05415067031051
• UDI-Public: (01)05415067031051(17)280331(10)9005718
• 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: 2025
• Device Explanted Year: 2025
• 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): 07/03/2025

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-PDAP-05-06-L
• Device Catalogue Number: 9-PDAP-05-06-L
• Device Lot Number: 9005718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2023
• 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
• Patient Age: 1 MO
• Patient Sex: Female
• Patient Weight: 3 KG