MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER TORQVUE DELIVERY SYSTEM; CATHETER, PERCUTANEOUS

Model Number	9-ITV07F180/80
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a amplatzer torqvue delivery system was selected for use.The use by date (ubd) was noted to be (b)(6) 2018, but the physician elected to use the device.The patient experienced no bleeding or infection and there were no adverse consequences to the patient.
Additional Manufacturer Narrative
An event of use of expired product was reported.The results of the investigation confirmed that amplatzer torqvue delivery system, lot 5225550, expired on 031 august 2018 which was prior to the reported event date of (b)(6) 2019.A review of distribution records confirmed that this product was distributed prior to its expiration date.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization; including verification of the expiration date listed on the product label.The root cause of the reported event is consistent with user error, per the site "the use by date was noted to be (b)(6) 2018, but the physician elected to use the device".Per the instructions for use, (b)(4) version b, "use on or before the last day of the expiration month that is printed on the product packaging label".

• Brand Name: AMPLATZER TORQVUE DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8478597
• Report Number: 2135147-2019-00095
• Device Sequence Number: 13879223
• Product Code: DQY
• UDI-Device Identifier: 00811806010793
• UDI-Public: 00811806010793
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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,Followup
• Report Date (Section B): 04/15/2019

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: 08/31/2018
• Device Model Number: 9-ITV07F180/80
• Device Lot Number: 5225550
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 04/15/2019
• 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: Other