MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER PICCOLO¿ DELIVERY SYSTEM; CATHETER DELIVERY SYSTEM

Model Number	9-PDS-04F-045
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not returning for evaluation.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) an amplatzer piccolo was selected for implant using a 4f amplatzer piccolo delivery system.All steps were performed per instructions for use (ifu).Prior to inserting the delivery system into the femoral vein, it was noted that air continuously observed in the hemostatic valve of the loader.The device was replaced with a new amplatzer piccolo delivery system.The patient status was stable.
Event or Problem Description
It was reported on 11 february an amplatzer piccolo was selected for implant using a 4f amplatzer piccolo delivery system.All steps were performed per instructions for use (ifu).Whilst inserting the loader into the tuohy connected to the catheter within the patient, prior to inserting the delivery system into the femoral vein, it was noted that air continuously observed in the hemostatic valve of the loader.A wet-to-wet connection was correctly established.Backflow was used to remove air bubbles.An attempt was made to disconnect the components of the delivery system and re-do device preparation.The device was replaced with a new 16mm amplatzer post-infarct muscular vsd occluder.The same delivery system was used to complete the procedure.The patient status was stable.
Additional Manufacturer Narrative
An event of air/gas in the device was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported air/gas in the device could not be determined.It is possible due to user techniques while de-aired the device; however, this cannot be confirmed.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.

• Brand Name: AMPLATZER PICCOLO¿ DELIVERY SYSTEM
• Common Device Name: CATHETER DELIVERY SYSTEM
• 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: 24663505
• Report Number: 2135147-2026-01811
• Device Sequence Number: 9243472
• Product Code: DQY
• UDI-Device Identifier: 05415067052926
• UDI-Public: (01)05415067052926
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K252417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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-PDS-04F-045
• Device Catalogue Number: 9-PDS-04F-045
• Device Lot Number: 11099194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2025
• 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
• Patient Age: 13 MO
• Patient Sex: Female