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

Model Number 9-ASD-028

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 11/24/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, during an amplatzer septal occluder implant, the screw of the delivery cable broke inside the septal occluder device.The occluder device was snared, and another amplatzer septal occluder was implanted with no reported patient consequences.

Manufacturer Narrative

The reported event of a the delivery cable end screw breaking off inside the septal occluder was confirmed, however, no anomalies were found with the 28 mm amplatzer septal occluder.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event could not be conclusively determined; however, per the instructions for use artmt100116885 rev.A, the recommended delivery system size for a 28 mm amplatzer septal occluder is 10f.The fracture of the end screw is consistent with an under-sizing of delivery system, which overloaded the end screw during advancement and deployment.

• 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: 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7133815
• MDR Text Key: 95368048
• Report Number: 2135147-2017-00173
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/30/2020
• Device Model Number: 9-ASD-028
• Device Catalogue Number: 9-ASD-028
• Device Lot Number: 5176807
• Other Device ID Number: 00811806010212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2015
• 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: 32 YR