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

Model Number 9-ASD-024

Device Problem Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a 24mm amplatzer septal occluder (lot number: 6184089) was deployed using a 10f amplatzer torqvue delivery system (lot number: 5790870).While repositioning the device, the la disc failed to be re-captured.The physician removed the device through the femoral vein and the case was aborted.The patient was taken to surgery to close the asd.The patient is reported to be stable.

Manufacturer Narrative

The reported event of failure to recapture the left atrial disc could not be confirmed.The results of this investigation confirmed the device all functional and dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8032663
• MDR Text Key: 125932796
• Report Number: 2135147-2018-00198
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010199
• UDI-Public: 00811806010199
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 9-ASD-024
• Device Catalogue Number: 9-ASD-024
• Device Lot Number: 6184089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 60