MAUDE Adverse Event Report: AGA MEDICAL CORP. AMPLATZER¿; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	9-AVP2-010
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The plug was deployed but would not release in the body.Md attempted to get it to release 3 times.Then md removed it.It released on the back table.

• Brand Name: AMPLATZER¿
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): AGA MEDICAL CORP.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 23050500
• Report Number: 23050500
• Device Sequence Number: 21274449
• Product Code: KRD
• UDI-Device Identifier: 00811806010380
• UDI-Public: (01)00811806010380(17)300430(10)10884748
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2025
• Report Date (Section F): 09/02/2025

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-AVP2-010
• Device Catalogue Number: 9-AVP2-010
• Device Lot Number: 10884748
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Date Report Sent to FDA: 09/02/2025