MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER VASCULAR PLUG II; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	9-AVP2-016
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2019, a 16mm amplatzer vascular plug ii was selected for implant.During preparation for the procedure, the physician discovered the device was damaged while inserting in the loading system.The device and the delivery system were retrieved and the case got canceled.No patient involvement was reported.
Additional Manufacturer Narrative
An event of the device being "damaged" was reported.The results of the investigation are inconclusive since 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 incident could not be conclusively determined.
Additional Manufacturer Narrative
The reported event of the device being damaged could not be confirmed.A forming hole was found in the waist of the device and is a result of the manufacturing process.The investigation confirmed the device met specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the reported event could not be conclusively determined.

• Brand Name: AMPLATZER VASCULAR PLUG II
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9528808
• Report Number: 2135147-2019-00428
• Device Sequence Number: 11457544
• Product Code: KRD
• UDI-Device Identifier: 00811806010410
• UDI-Public: 00811806010410
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K071125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2020

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 Expiration Date: 12/31/2023
• Device Model Number: 9-AVP2-016
• Device Catalogue Number: 9-AVP2-016
• Device Lot Number: 6809139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 03/30/2020; 08/04/2020
• Initial Report FDA Received Date: 12/29/2019
• Supplement Report FDA Received Date: 03/30/2020; 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1