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

Catalog Number 9-PDA-003

Device Problems Difficult to Insert (1316); Retraction Problem (1536)

Patient Problem No Code Available (3191)

Event Date 08/19/2014

Event Type  malfunction  

Event Description

Attempting to place duct occluder into patent ductus arteriosus (pda).Device did not seat well across defect.The device should collapse to be drawn back into the delivery system.Device failed to collapse and could not be retrieved easily with bailout system.Procedure time extended by approx two (2) hours.

• Brand Name: AMPLATZER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORP.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 4120658
• MDR Text Key: 20293613
• Report Number: 4120658
• Device Sequence Number: 1
• Product Code: MLV
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/03/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9-PDA-003
• Device Lot Number: 4220136
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/03/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2014
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS; THIS CHILD (B)(6) WAS UNDERGOING A CARDIAC; CATHETERIZATION.
• Patient Age: 11 MO