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U.S. Department of Health and Human Services

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

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AGA MEDICAL CORPORATION TORQVUE SHEATH 12F 080CM 45X45 PKG STER DELIVERY SHEATH Back to Search Results
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)).

 
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Brand NameTORQVUE SHEATH 12F 080CM 45X45 PKG STER
Type of DeviceDELIVERY 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 Key8042736
MDR Text Key126278025
Report Number2135147-2018-00193
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
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 Received11/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2020
Device MODEL Number9-TV45X45-12F-080
Device LOT Number5952392
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/11/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/19/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/06/2018 Patient Sequence Number: 1
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