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

Model Number 9-ASD-028

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 03/03/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, a 28mm amplatzer septal occluder was selected for implant.During deployment, the device was unable to be released from the delivery cable and the patient was referred to surgery.No patient consequences were reported.Additional information has been requested.

Manufacturer Narrative

The reported event of difficulty releasing the device from the delivery cable could not be confirmed.The investigation confirmed the device met functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the reported event could not be conclusively determined.

Event Description

On (b)(6) 2019, a 28mm amplatzer septal occluder was selected for implant.During deployment, the device was unable to be released from the delivery cable and the patient was referred to surgery.No patient consequences were reported.Since no additional information has been provided, we will proceed with closure.If additional information becomes available, the file will be reopened.

• 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: 8538089
• MDR Text Key: 142736954
• Report Number: 2135147-2019-00121
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067019325
• UDI-Public: 05415067019325
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/25/2019

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: 12/31/2020
• Device Model Number: 9-ASD-028
• Device Catalogue Number: 9-ASD-028
• Device Lot Number: 5339975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 04/22/2019
• Supplement Dates Manufacturer Received: 05/29/2019
• Supplement Dates FDA Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2016
• 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