MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number	9-ASD-019
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information regarding this event has been requested.If returned, investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2020, a 19mm amplatzer septal occluder(aso) was selected for implant.When deploying the aso in the left atrium, the aso became detached from the delivery cable.The physician attempted to remove the aso percutaneously by a snare catheter but failed.An emergency surgery was performed on the same date.It was thought that the aso had not been connected firmly enough to the delivery cable during preparation; the physician attributes the issue to his procedure and not due to the aso failure.There was a delay in the procedure.
Additional Manufacturer Narrative
Correction information for h1.Additional information for b5, g4, g7, h2, h6, and h10.An event of premature detachment of the device was reported.A more comprehensive assessment could not be performed as the device 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 information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
On (b)(6) 2020, a 19mm amplatzer septal occluder (aso) was selected for implant.The device was prepped per instructions in the ifu.When deploying the aso in the left atrium, the aso became detached from the delivery cable.The physician attempted to remove the aso percutaneously by a snare catheter but failed.An emergency surgery was performed on the same day to remove the device.The physician attributes the premature detachment to be due to not connecting the device securely to the delivery cable during preparation.There was a delay in the procedure.The patient is currently stable and recovered from the procedure.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10317624
• Report Number: 2135147-2020-00331
• Device Sequence Number: 1020179
• Product Code: MLV
• UDI-Device Identifier: 00811806010168
• UDI-Public: 00811806010168
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 9-ASD-019
• Device Catalogue Number: 9-ASD-019
• Device Lot Number: 7042105
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention