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

Model Number DS-TV45X45-12F-080

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

Patient Problems Hematoma (1884); Pseudoaneurysm (2605)

Event Date 06/06/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020, a 20 mm amplatzer amulet occluder was selected for implant.On (b)(6) 2020, the patient became hospitalized and was monitored due to a hematoma and suspected pseudoaneurysm at the puncture site requiring no intervention.Imaging revealed there was no av-fistula.On (b)(6) 2020, the patient was discharged home.

Manufacturer Narrative

Additional information: d10, g4, h2, h3, h6 & h10.An event of hematoma and suspected aneurysm at the puncture site was reported.A more comprehensive assessment could not be performed as 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Type of Device: AMPLATZER TORQVUE DELIVERY SYSTEM
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10240811
• MDR Text Key: 197827206
• Report Number: 2135147-2020-00269
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: DS-TV45X45-12F-080
• Device Lot Number: 6807984
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 89 YR
• Patient Weight: 93