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

Model Number	9-ASD-036
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	04/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, a 36mm amplatzer septal occluder was chosen for procedure using a non-abbott 14fr delivery sheath.During deployment, the physician noted that the device was not taking the desired shape, and a cobra deformation was observed.The device was retrieved back, and no replacement device was used.There was no interaction with cardiac structures during deployment, and there was no angulation or kink noted in the delivery system.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
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 deploying deformed could not be confirmed.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.Deformed bent wires were noted on the distal disc, consistent with damage during use.Information from the field indicated that a non-abbott 14f sheath was used and the amplatzer septal occluder instructions for use, has the largest recommended sheath size as a 13f.The internal diameter of the non-abbott sheath is unknown, therefore it cannot be conclusively determined if the larger sheath size contributed to the reported event.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.Na.
Event or Problem Description
N/a.

• 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: 14391155
• Report Number: 2135147-2022-00265
• Device Sequence Number: 5149350
• Product Code: MLV
• UDI-Device Identifier: 05415067019363
• UDI-Public: 05415067019363
• 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: 04/30/2022
• Device Model Number: 9-ASD-036
• Device Catalogue Number: 9-ASD-036
• Device Lot Number: 5986734
• 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: 04/15/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 14FR. MULLINS SHEATH
• Patient Sex: Unknown