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

Model Number DS-TV45X45-12F-080

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Date 02/28/2020

Event Type  Injury  

Manufacturer Narrative

An event of pseudoaneurysm was reported.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 and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2020, a 22mm amplatzer amulet occluder was selected for implant using a 12f torqvue delivery system.On (b)(6) 2020, a pseudoaneurysm was discovered, the patient was hospitalized and was treated with injection of 800ie thrombin at the right inguinal puncture area.The patient was discharged on (b)(6) 2020 in good and stable condition.

• Type of Device: TORQVUE DELIVERY SYSTEM
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9861980
• MDR Text Key: 184469839
• Report Number: 2135147-2020-00103
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: DS-TV45X45-12F-080
• Device Catalogue Number: DS-TV45X45-12F-080
• Device Lot Number: 7150048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 68