MAUDE Adverse Event Report: ABBOTT MEDICAL (SH-PLYMOUTH) AMPLATZER DUCT OCCLUDER II; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number	9-PDA2-04-06
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 4/6mm amplatzer duct occluder ii was selected for an implant on (b)(6) 2022.During deployment, the device was not opening in a desired shape appeared bulbous.Device was removed from the patient prior to released from the delivery cable.There was no angulation or kink noticed in the delivery system and no interaction with atrial structures during deployment.Device was replaced with a new 4/6mm amplatzer duct occluder ii that completed the procedure.Patient stable, no additional information was provided.
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Additional Manufacturer Narrative
The reported event of bulbous 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 II
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL (SH-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL (SH-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13675017
• Report Number: 3005334138-2022-00132
• Device Sequence Number: 4995500
• Product Code: MAE
• UDI-Device Identifier: 00811806011219
• UDI-Public: 00811806011219
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2022

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: 02/28/2022
• Device Model Number: 9-PDA2-04-06
• Device Catalogue Number: 9-PDA2-04-06
• Device Lot Number: 5903060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown