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

Model Number	9-PDA-006
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The 10/8mm amplatzer duct occluder (ado) would not advance through the 6f amplatzer torqvue 180 delivery system (dtv180).The ado was removed and replaced with a 10/8mm lifetech cera device which was successfully advanced.The user commented that the aortic side of the ado was slightly bigger than the 10/8mm lifetech cera device and questioned if the ado in the 9-pda-006 packaging was correct.The procedure was extended approximately 20-30 minutes due to this event.The patient was stable throughout the procedure and is reported to be stable.
Additional Manufacturer Narrative
The reported event of an inability to advance the occluder through the delivery system could not be confirmed.The nitinol braiding at the proximal end of the occluder was bunched, which contributed to difficulty loading the occluder into the delivery sheath.As this damage is consistent with a forceful attempt to advance the occluder, and potentially contributed to the advancement difficulty, it is not possible to determine the extent of this difficulty or the bunching of the nitinol wires prior to use in the field.Additionally, despite this damage, the occluder was able to be successfully deployed through a stock 6f delivery system, meeting functional specifications.The occluder met 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 could not be conclusively determined.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7904462
• Report Number: 2135147-2018-00161
• Device Sequence Number: 1787463
• Product Code: MAE
• UDI-Device Identifier: 00811806011134
• UDI-Public: 00811806011134
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 9-PDA-006
• Device Catalogue Number: 9-PDA-006
• Device Lot Number: 5413327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Weight: 10