MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER¿; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-ASD-010

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 12/21/2021

Event Type  malfunction  

Event Description

Prepped but when taken out of the package it was deformed.

• Brand Name: AMPLATZER¿
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 13541579
• MDR Text Key: 285673868
• Report Number: 13541579
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2021,12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-ASD-010
• Device Catalogue Number: 9-ASD-010
• Device Lot Number: 8021598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1