MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER TORQVUE DELIVERY SYSTEM

Model Number	9-ITV10F45/80
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event of premature release could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the instructions for the amplatzer septal occluder artmt100116885 ver.A, "do not rotate the delivery cable" while advancing the device through the delivery sheath.
Event or Problem Description
During the procedure, the 20 mm amplatzer septal occluder (aso) prematurely released inside the 10f amplatzer torqvue 45 delivery system and embolized to the pulmonary artery.The left atrial disc had been fully deployed and the right atrial disc was partially deployed when it became detached.An attempt to snare the aso was performed; however, the patient was sent to surgery for device removal and defect closure.The patient condition before and during the procedure was stable.The patient is recovering and is reported to be stable.The device and delivery cable were discarded and were not returned for analysis.

• Brand Name: AMPLATZER TORQVUE DELIVERY SYSTEM
• Common Device Name: DELIVERY SYSTEM
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7856207
• Report Number: 2135147-2018-00145
• Device Sequence Number: 16761462
• Product Code: DQY
• UDI-Device Identifier: 00811806010878
• UDI-Public: 00811806010878
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K072313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2018

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: 02/29/2020
• Device Model Number: 9-ITV10F45/80
• Device Catalogue Number: 9-ITV10F45/80
• Device Lot Number: 5907782
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 09/07/2018
• 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: Hospitalization; Required Intervention