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

Model Number	DUCT OCCLUDER II
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	03/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, a 4/6mm amplatzer duct occluder ii was chosen for implant to treat patent ductus arteriosus (pda) utilizing a 6f non-abbott delivery sheath.During deployment it was noted that the device was forming a cobra shape, so the device was removed.No replacement device was used and the procedure was cancelled.There was no angulation or kink noticed in the delivery system.The patient remained hemodynamically stable throughout the procedure.There were no adverse patient effects and no clinically significant delay.
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 device deformity could not be confirmed.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Information from the field indicated that there was no anatomical interference or any angulation or kink in the delivery system upon deployment and 6f size delivery system was used.The cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Per the amplatzer duct occluder ii instructions for use, artmt100092303 revision a, the reference the sheath size delivery system for use with a 4-6 mm amplatzer duct occluder is an 4f.
Event or Problem Description
It was reported that on (b)(6) 2023, a 4/6mm amplatzer duct occluder ii was chosen for implant to treat patent ductus arteriosus (pda) utilizing a 6f non-abbott delivery sheath.During deployment it was noted that the device was forming a cobra shape, so the device was removed.No replacement device was used and the procedure was cancelled.There was no angulation or kink noticed in the delivery system and the device did not interact with any cardiac structures.The patient remained hemodynamically stable throughout the procedure.There were no adverse patient effects and no clinically significant delay.

• Brand Name: AMPLATZER DUCT OCCLUDER II
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16715454
• Report Number: 2135147-2023-01580
• Device Sequence Number: 7264159
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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 Expiration Date: 05/31/2023
• Device Model Number: DUCT OCCLUDER II
• Device Catalogue Number: 9-PDA2-04-06
• Device Lot Number: 6503157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6F DELIVERY SHEATH (MULLIN'S)
• Patient Sex: Unknown