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

Model Number	9-ITV08F45/80
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, a 14mm amplatzer muscular vsd occluder was selected for implant.During the procedure, after positioning the device, the physician performed a left ventricular angiography.A large leak was observed from the right ventricle to the pericardium.The physician performed a percutaneous pericardiocentesis.The device was released.The patient remained hemodynamically stable throughout the procedure and is transferred to cardiac intensive care.
Additional Manufacturer Narrative
An event of pericardial effusion was reported.The results of the investigation are inconclusive since the device remains implanted and was not accessible 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.

• 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: 9733691
• Report Number: 2135147-2020-00065
• Device Sequence Number: 3108210
• Product Code: DQY
• UDI-Device Identifier: 00811806010847
• UDI-Public: 00811806010847
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/21/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 9-ITV08F45/80
• Device Catalogue Number: 9-ITV08F45/80
• Device Lot Number: 7184925
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 02/21/2020
• 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; Required Intervention