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

Model Number 9-ASD-010

Device Problems Structural Problem (2506); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2022

Event Type  malfunction  

Event Description

The 1st device was prepped, flushed with hep saline and amplatzer loaded to the delivery system and the device was flushed.When the device was deployed into the pulmonary artery it seemed misshapened and it would not allow for closure.The device was then removed from the patient the amplatzer tried to reshape and check the closure but didn¿t seem to work properly (lot number 8031289) another device was used, prepped in the same fashion.The 2nd device when loaded seemed like it wasn¿t tracking well on the delivery guide and the torque was hung up midway through, it was even forced a little to push it through but still was hung up.(lot # on 2nd device 7712846).Delivery and a 3rd device was used and worked.So, it was unknow if the devices were defective or the delivery was defective.(delivery lot # 8412603).

• Brand Name: AMPLATZER¿
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 14753804
• MDR Text Key: 295122515
• Report Number: 14753804
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/24/2022,05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-ASD-010
• Device Catalogue Number: 9-ASD-010
• Device Lot Number: 8031289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/24/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: White