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U.S. Department of Health and Human Services

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

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AGA MEDICAL CORPORATION AMPLATZER TORQVUE DELIVERY SYSTEM Back to Search Results
Model Number 9-ITV09F45/80
Device Problem Use of Device Problem (1670)
Patient Problems Air Embolism (1697); Stroke/CVA (1770); Death (1802)
Event Date 06/14/2018
Event Type  Death  
Event Description
On (b)(6) 2018, a 9fr amplatzer torqvue 45 delivery system was selected for use in a pfo closure in an (b)(6) with "platypnée orthodéoxie"(dyspnea and desaturation when in upright position). During the procedure, the physician was removing the dilator from the sheath and due to extremely low left atrial pressures, a bubble escaped from the sheath into the left atrium and ultimately the patient suffered a massive stroke and died. The user does not believe there was a device malfunction. The physician was reported to not have used the tuohy adapter which prevents air embolisms. Patient¿s comorbidities include dyspnea post thoracic surgery and an extremely low bmi (17. 1). Hospital reports were not available for this event.
 
Manufacturer Narrative
Aan event of dyspnea, stroke, and patient death 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. Based on the information received, the cause of the reported incident could not be conclusively determined; however, there was no evidence of a device malfunction and it is reported the patient had multiple comorbidities including dyspnea, and a low bmi of 17. 1. Information from the field indicated, "the physician was reported to not have used the tuohy adapter which prevents air embolisms. " per ifu 100096269 version b, "allow back-bleeding to purge any air from the delivery catheter. Flush all parts of the hemostasis valve. Connect the distal end of the hemostasis valve to the delivery catheter. Remember to close the stopcock on the sidearm of the hemostasis valve. ".
 
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Brand NameAMPLATZER TORQVUE DELIVERY SYSTEM
Type of DeviceDELIVERY 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
elizabeth boltz
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key7695937
MDR Text Key114229632
Report Number2182269-2018-00088
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00811806010861
UDI-Public00811806010861
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K072313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2021
Device Model Number9-ITV09F45/80
Device Catalogue Number9-ITV09F45/80
Device Lot Number6384704
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 Received06/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/29/2018
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/17/2018 Patient Sequence Number: 1
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