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

Model Number	9-PDAP-04-02-L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Sepsis (2067); Tachycardia (2095)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned 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 that on (b)(6) 2025, a 4mm x 2mm amplatzer piccolo occluder was successfully implanted in a patient.On (b)(6) 2025, it's noted that the patient had positive blood cultures showing yeast.
Event or Problem Description
Subsequent to the previously filed report additional information was received that the procedure was performed in a sterile environment.The 4mm x 2mm amplatzer piccolo occluder was not mishandled during device preparation or procedure.The occluder was delivered using a 4f amplatzer torqvue lp delivery catheter.Blood cultures were positive for candida glabrata, the patient had clinical signs of sepsis, tachycardia, episodes of apnea/bradycardia, and hypotension.The patient was administered fluconazole, micafungin, and required inotropic support with dopamine and norepinephrine.The cause of the yeast infection is unknown, but not believed to be related to the occluder.There was a prolonged hospitalization due to this event.No additional information was provided.
Additional Manufacturer Narrative
It was reported that the patient had positive blood cultures showing yeast post 10 days piccolo device implant.The patient had clinical signs of sepsis, tachycardia, episodes of apnea/bradycardia, and hypotension.Reportedly, the cause of the yeast infection was unknown, but not believed to be related to the occluder.There was a prolonged hospitalization due to this event.A returned device assessment could not be performed as the device remains implanted and 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 specifications.Based on the information received, the cause of the reported infection could not be determined.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes added: h6 health effect - clinical code: 2067, 2095, 1751, 1914.H6 health effect - impact code: 4641, 4607.

• 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: 22373157
• Report Number: 2135147-2025-03572
• Device Sequence Number: 8025617
• Product Code: MAE
• UDI-Device Identifier: 05415067031006
• UDI-Public: (01)05415067031006(17)290430(10)10341300
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 08/22/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-PDAP-04-02-L
• Device Catalogue Number: 9-PDAP-04-02-L
• Device Lot Number: 10341300
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2024
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 1 MO
• Patient Sex: Male