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

Model Number	DUCT OCCLUDER
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, a 5-4mm amplatzer duct occluder was selected for implant using a 5f amplatzer torqvue delivery system.It was noted during procedure that the occluder was unable to be inserted from the loader into the delivery system.It also noted that the occluder became prematurely detached from the delivery cable and stuck in the part of the delivery system that was outside of the patient.The patient does not have a tortuous anatomy and there was no kink or angulation noted on the 5f amplatzer torqvue delivery system.The 5-4mm amplatzer duct occluder was not mishandled or damaged at any point during device preparation.The 5-4mm amplatzer duct occluder was sized using angiogram measurements.The decision was made to cut the 5f amplatzer torqvue delivery system, remove it, successfully retrieve the detached 5-4mm amplatzer duct occluder, reattached the occluder to the delivery cable, and successfully implant it using a replacement 6f amplatzer torqvue delivery system.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects reported.The patient was stable at the time of report.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of the occluder becoming prematurely detached from the delivery cable and stuck in the delivery system during the procedure was reported.A returned device assessment could not be performed as the device remains implanted and 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 available information, the root 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): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16556900
• Report Number: 2135147-2023-01220
• Device Sequence Number: 3022011
• Product Code: MAE
• UDI-Device Identifier: 00811806011103
• UDI-Public: 00811806011103
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

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 Model Number: DUCT OCCLUDER
• Device Catalogue Number: 9-PDA-003
• Device Lot Number: 8431435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2022
• 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