MAUDE Adverse Event Report: AGA MEDICAL CORPORATION TORQVUE SHEATH 12F 080CM 45X45 PKG STER; DELIVERY SHEATH

Model Number 9-TV45X45-12F-080

Device Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); High Blood Pressure/ Hypertension (1908)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

An event of hypotension and air embolus were 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2018, a 12f amplatzer torqvue 45x45 delivery sheath was used in the us ide to implant an amplatzer amulet device.During the procedure, the patient had a drop in blood pressure that was treated with epinephrine and dobutamine.It was then noted that the first sheath contained air bubbles.The delivery system was removed and exchanged.Echocardiogram was performed and right ventricle dysfunction was observed.An arterial line was placed.Abnormal arterial blood gas and hypotension were noted and treated.There was suspected air in the left atrial to right coronary artery.After the procedure, the patient was reportedly confused but cleared gradually.The patient was sent to the ccu to wean off the epi and dobutamine.On (b)(6)2018, the patient was discharged home.Of note, the patient at baseline had a trivial pericardial effusion which remained unchanged post procedure and was not treated (clinical study patient id: (b)(6)).

• Brand Name: TORQVUE SHEATH 12F 080CM 45X45 PKG STER
• Type of Device: DELIVERY SHEATH
• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8042736
• MDR Text Key: 126278025
• Report Number: 2135147-2018-00193
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 05415067025883
• UDI-Public: 05415067025883
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 9-TV45X45-12F-080
• Device Lot Number: 5952392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2017
• 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; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 89