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

Model Number	9-PDAP-05-02-L
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
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 on (b)(6) 2026, a 5mm x 2mm amplatzer piccolo occluder was chosen for implant using a 4f amplatzer torqvue lp delivery system.During the procedure, while implanting, after the device was loaded into the loader and advanced through the delivery system, it did not progress as intended.Upon withdrawal, the occluder was observed to have detached and remained inside the delivery system.The device did not come in contact with the patient.The entire system was subsequently removed, the sheath was reinserted, and the procedure was completed using a new 4f amplatzer torqvue lp delivery system and a new 5 mm x 2 mm amplatzer piccolo occluder.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
An event of a premature separation was reported.The device was returned to abbott for investigation.The delivery cable was returned in a deformed state but met functional specifications when analyzed under non-physiological conditions.The occluder was not returned for investigation.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 available information, the cause for the reported premature separation could not be determined.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.
Event or Problem Description
N/a.

• 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: 24223993
• Report Number: 2135147-2026-00546
• Device Sequence Number: 9238429
• Product Code: MAE
• UDI-Device Identifier: 05415067031037
• UDI-Public: (01)05415067031037(17)280430(10)9070896
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/17/2026

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-05-02-L
• Device Catalogue Number: 9-PDAP-05-02-L
• Device Lot Number: 9070896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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: 3 MO
• Patient Sex: Female