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

Model Number 9-PDA-007

Device Problems Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 11/10/2019

Event Type  malfunction  

Event Description

A 12/111110 amplatzer duct occluder deployed and following deployment, the device embolized to the pa (pulmonary artery).The device was retrieved in the cath lab.Device was saved and kept in the cath lab.

• 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: 9383046
• MDR Text Key: 168286944
• Report Number: 9383046
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9-PDA-007
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2019
• Date Report to Manufacturer: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6205 DA
• Patient Weight: 45