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

Model Number	9-ITV07F45/80
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a 16mm amplatzer septal occluder (aso) and 7f amplatzer torqvue 45 delivery system (dtv45) were selected.During deployment, the device formed into a cobra shape and was difficult to resheath.A 9f amplatzer torqvue exchange system (etv) was used to remove the 16mm aso.A second 16mm aso was deployed using the original dtv45 delivery cable through the 9f etv to successfully complete the procedure.Per report the procedure was extended by 36 minutes.The patient did not have any adverse consequences and was discharged the next day.
Additional Manufacturer Narrative
The reported event of difficulty re-sheathing the occluder could not be confirmed.The investigation confirmed the device met functional specifications when analyzed at abbott under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

• 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: 8067145
• Report Number: 2135147-2018-00202
• Device Sequence Number: 13941490
• Product Code: DQY
• UDI-Device Identifier: 00811806010816
• UDI-Public: 00811806010816
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2018

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: 06/30/2021
• Device Model Number: 9-ITV07F45/80
• Device Catalogue Number: 9-ITV07F45/80
• Device Lot Number: 6536730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/02/2018
• 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
• Patient Age: 2 YR
• Patient Weight: 9