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

Model Number 9-ASD-034

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Arrhythmia (1721)

Event Date 06/18/2020

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 healthcare provider emailed stating that he had a 34mmaso occluder that was defective.The user reports the occlude came off of the cable without any manipulation.Additional information was requested asking further questions regarding the statement, the following response was received: per dr.(b)(6), the physician performing the procedure reports.A 34 mm amplatzer septal occluder was chosen and determined to be defective and it was deemed to be too large (so we used a smaller one).A replacement was chosen, a 30mm amplatzer septal occluder.According to the implanting physician, the patient developed some brief runs of vt.The site reports the patient to be in stable condition.What happened that the device is being considered as defective? came off the cable w/o any manipulation.

Manufacturer Narrative

Additional information: g4, h2, h3 h6 & h10.An event of an amplatzer septal occluder coming off the cable without any manipulation was reported.The investigation confirmed the device met functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.

• 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: 10213635
• MDR Text Key: 198886667
• Report Number: 2135147-2020-00297
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067019356
• UDI-Public: 05415067019356
• 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,health
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 9-ASD-034
• Device Catalogue Number: 9-ASD-034
• Device Lot Number: 5541853
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 06/30/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention