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

Model Number 9-ASD-019

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

Further information regarding this event has been requested.If returned, investigation results will be provided in a subsequent submission.

Event 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.

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 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
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10317624
• MDR Text Key: 200246420
• Report Number: 2135147-2020-00331
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010168
• UDI-Public: 00811806010168
• Combination Product (y/n): N
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention