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

Model Number	9-PDA-003
Medical Device Problem Codes	Difficult to Insert (1316); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2019, a 5/4 mm pda occluder was selected for implant using a torqvue delivery system 5fr 90/080.During the procedure, the occluder failed to advance into the delivery sheath.The physician attempted to retract the device, but it remained stuck in the loading system.A new 5/4mm pda occluder and torqvue 5fr 90/080 were selected.Upon advancement, the occluder was stuck in the sheath again, but this time it was successfully retrieved into the loading system.A third delivery system torqvue 6fr was selected and successfully used to implant the second pda occluder.The patient is reported to be stable.Manufacturer report number: 2135147-2020-00019, 2135147-2020-00020, 2182269-2020-00001.
Additional Manufacturer Narrative
Additional information: d10, h3, h10; correction: h6.An event of difficulty advancing the occluder through into the sheath could not be confirmed.The investigation confirmed the device met dimensional 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 event could not be conclusively determined.
Additional Manufacturer Narrative
Correction information for d2 additional information for g4, g7, h2, h10.

• 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: 9606798
• Report Number: 2135147-2020-00005
• Device Sequence Number: 1046810
• Product Code: MAE
• UDI-Device Identifier: 00811806011103
• UDI-Public: 00811806011103
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 9-PDA-003
• Device Catalogue Number: 9-PDA-003
• Device Lot Number: 6869766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 04/24/2020; 11/10/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 04/28/2020; 12/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 9-ITV05F180/60, 6398620; 9-PDA-003, 6869767; 9-TVLP5F90/080, 6398620
• Outcome Attributed to Adverse Event: Required Intervention