MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER DUCT OCCLUDER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number 9-PDA-003

Device Problems Difficult to Insert (1316); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

An event of device deformation in the sheath and inability to deploy a 5/4 ado was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2020, an amplatzer duct occluder ii (adoii) was selected for implant first.However, the adoii did not fit well in the patient's defect, although there was no problem with the adoii itself.A 5/4mm amplatzer duct occluder (ado) was selected next, using a 180/60 5f amplatzer torqvue delivery system.However, the ado deformed and got stuck within the sheath; the ado was not able to be deployed from the delivery system.The delivery system was replaced with another one, but still the ado could not be deployed.The ado was replaced with another ado, and the procedure was completed with no consequence to the patient.

Manufacturer Narrative

Corrected information: d2.Additional information: g4, h2, and h10.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9872074
• MDR Text Key: 184842787
• Report Number: 2135147-2020-00128
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 9-PDA-003
• Device Catalogue Number: 9-PDA-003
• Device Lot Number: 5682013
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 6 YR