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

Model Number	9-ASD-034
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	06/18/2020
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 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.
Additional 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
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10213635
• Report Number: 2135147-2020-00297
• Device Sequence Number: 16712671
• Product Code: MLV
• UDI-Device Identifier: 05415067019356
• UDI-Public: 05415067019356
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 09/30/2020
• 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