MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; CARDIAC OCCLUSION DEVICE

Model Number 9-ASD-014

Device Problem Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 06/26/2014

Event Type  Injury  

Event Description

A 14mm amplatzer septal occluder (aso) was deployed in a multi-fenestrated atrial septal defect.Upon release a shunt was still seen so the aso was percutaneously removed.A 17mm aso was successfully implanted.

Manufacturer Narrative

The 14mm aso was received at sjm and decontaminated.The aso was grossly and microscopically examined, and no anomalies were found.It met dimensional specifications when measured with a caliper.The aso was loaded into a test 7f loader, deployed and retracted without difficulty or deformation, under non-physiological conditions.The device history record for this product was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: CARDIAC OCCLUSION DEVICE
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 3927050
• MDR Text Key: 4495934
• Report Number: 2135147-2014-00066
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2016
• Device Model Number: 9-ASD-014
• Device Catalogue Number: 9-ASD-014
• Device Lot Number: 1112135026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2014
• Initial Date FDA Received: 07/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR