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

Model Number 9-PDA-004

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020, a 5/4 amplatzer duct occluder was selected for implant, but was determined to be too small to treat the defect.The device was not released from the cable and was safely removed from the patient.A 6/4 amplatzer duct occluder (lot: 7002193) was then selected for implant, but upon deployment the device deformed into a cobra shape.The device was not released from the cable and was removed from the patient.A second 6/4 amplatzer duct occluder was then selected and was successfully implanted.There are no known complications with this case.There was no clinically significant delay in procedure and the patient remained hemodynamically stable throughout the procedure.

Manufacturer Narrative

The report was submitted under the incorrect product code.The correct product code is mae.

Manufacturer Narrative

Additional information for: g4, g7, h2, h3, h6, and h10.The reported event of device deformation could not be confirmed.The investigation confirmed the device met visual and 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.The cause of the reported incident could not be conclusively determined.

• 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: 9912585
• MDR Text Key: 186212975
• Report Number: 2135147-2020-00110
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 00811806011110
• UDI-Public: 00811806011110
• 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,health
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 9-PDA-004
• Device Catalogue Number: 9-PDA-004
• Device Lot Number: 7002193
• Was Device Available for Evaluation?: Yes
• 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): Required Intervention