MAUDE Adverse Event Report: ABBOTT MEDICAL Amplatzer Piccolo; Occluder, Patent Ductus, Arteriosus

Model Number	9-PDAP-03-06-L
Medical Device Problem Codes	Fracture (1260); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
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) 2025, a 3 mm x 6 mm amplatzer piccolo occluder was chosen for implant using a 4f amplatzer torqvue lp delivery system.During the procedure, the cable broke inside the patient while the piccolo prosthesis was partially unscrewed.The occluder got separated from the delivery cable before it was deployed.The clinical team was uncertain how this occurred.The devices were eventually retrieved with difficulty using snares.The procedure was completed using a replacement device.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.

• 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 ; +1(651)756-5400
• MDR Report Key: 24036224
• Report Number: 2135147-2026-00235
• Device Sequence Number: 10482031
• Product Code: MAE
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-PDAP-03-06-L
• Device Catalogue Number: 9-PDAP-03-06-L
• Device Lot Number: 10943934
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/26/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown