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U.S. Department of Health and Human Services

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

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AGA MEDICAL CORPORATION AMPLATZER TORQVUE DELIVERY SYSTEM CATHETER, PERCUTANEOUS Back to Search Results
Model Number 9-ITV09F45/80
Device Problem Biocompatibility (2886)
Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Intracranial Hemorrhage (1891); ST Segment Elevation (2059)
Event Date 11/12/2019
Event Type  Injury  
Manufacturer Narrative
An event of air embolism due to a spontaneous deep breath taken by the patient while connecting the loader to the delivery sheath, st-elevation, cardiac arrest, and hemorrhagic stroke 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 and the product met all specifications at the time of commercialization. Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
On (b)(6) 2019, a 25mm amplatzer pfo occluder was implanted. While connecting the loader to the delivery sheath, the patient spontaneously took a deep breath which caused air embolism, which was suspected due to ecg changes. The patient had st-elevation, cardiac arrest and was treated with left heart catherization and stabilized with medication. The device was implanted and the patient was successfully resuscitated. The patient was referred to computed tomography (ct) scan, which revealed hemorrhagic stroke and was sent to further treatment to a stroke center. The patient is currently stable.
 
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Brand NameAMPLATZER TORQVUE DELIVERY SYSTEM
Type of DeviceCATHETER, PERCUTANEOUS
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
pamela yip
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key9423965
MDR Text Key177824727
Report Number2135147-2019-00426
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 12/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9-ITV09F45/80
Device Catalogue Number9-ITV09F45/80
Device Lot Number7108972
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 Received11/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/30/2019
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: 12/06/2019 Patient Sequence Number: 1
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