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

Catalog Number	9-PDA-004
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	08/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, a 6-4mm amplatzer duct occluder was chosen for implant into patent ductus arteriosus (pda), using 06f amplatzer torqvue delivery system.During deployment, the device was noted to deform.There was no angulation or kink noticed in the delivery system.There was no interaction with cardiac structures during deployment.The device was removed and a replacement 6-4mm amplatzer duct occluder was successfully implanted.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
An event of device deformity was reported.One video was received from the field appearing to show the device upon deployment.The device was returned to abbott for investigation and 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.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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 (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: 17722677
• Report Number: 2135147-2023-03923
• Device Sequence Number: 20636308
• Product Code: MAE
• UDI-Device Identifier: 00811806011110
• UDI-Public: 00811806011110
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 09/11/2023

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 Catalogue Number: 9-PDA-004
• Device Lot Number: 8961343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2023
• 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: AMPLATZER TORQVUE DELIVERY SYSTEM
• Patient Sex: Unknown