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

Model Number 9-ACP2-010-025

Device Problem Fracture (1260)

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

Event Date 06/22/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020, a 25mm amulet device was chosen for procedure.The device was attached to the sheath adaptor which was attached to the 14f amulet sheath.The sheath adaptor disconnected from the amulet sheath while trying to advance the device.There was concern that air may have been introduced into the system through loss of connection.The sheath adaptor was reconnected to the sheath but the physician had difficulty advancing the device.On examination the sheath adaptor appeared to have been damaged, and come apart damaging the device.A new 25mm amulet device was prepared along with new sheath adaptor and successfully deployed.On (b)(6) 2020, the clinical site confirmed the need to replace the device to prevent serious injury.

• Brand Name: AMPLATZER AMULET
• 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: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10263960
• MDR Text Key: 198519637
• Report Number: 2135147-2020-00315
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806013497
• UDI-Public: 00811806013497
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/13/2020

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 Model Number: 9-ACP2-010-025
• Device Catalogue Number: 9-ACP2-010-025
• Device Lot Number: 7281442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2019
• 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): Life Threatening; Required Intervention