MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number	9-ASD-028
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	03/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported a 28 mm amplatzer septal occluder was chosen for procedure on (b)(6)2022.During deployment of the occluder, the device presented with a deformation and the device was not placed.The patient remained stable throughout the procedure.The patient was noted to have been discharged.There was no clinically significant delay in procedure and no adverse patient effects.
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 and dimensional specifications when analyzed under non-physiological conditions.A broken wire was noted on the distal disc.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14156021
• Report Number: 2135147-2022-00179
• Device Sequence Number: 17544989
• Product Code: MLV
• UDI-Device Identifier: 05415067019325
• UDI-Public: 05415067019325
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 09/01/2022

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: 10/31/2024
• Device Model Number: 9-ASD-028
• Device Catalogue Number: 9-ASD-028
• Device Lot Number: 7281654
• 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: 03/24/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2019
• 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 DS 9-ITV10F45/80 LOT: 6444362
• Patient Sex: Unknown