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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); Myocardial Infarction (1969); Pain (1994)
Event Date 03/26/2018
Event Type  Injury  
Manufacturer Narrative

An embolic event 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.

 
Event Description

On (b)(6) 2018, a 35 mm amplatzer pfo occluder was selected for implant with a 9 fr amplatzer torqvue delivery system. After the device was deployed and released, the patient had st elevation and pain. As pain increased, a catheter was placed in the right coronary and confirmed an air bubble was located in the distal rca. The patient was placed under observation and the pain resided. The user believes the air was introduced into the delivery system during preparation of the amplatzer torqvue delivery system and was released into the right coronary with the release of the device. The device remains implanted and the patient is reported to be stable. Patient identifier, age, gender, and weight are unavailable for this event.

 
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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
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key7434280
MDR Text Key105606397
Report Number2135147-2018-00049
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK072313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Inspection
Type of Report Initial
Report Date 04/16/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/16/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number9-ITV09F45/80
Device Catalogue Number9-ITV09F45/80
Device LOT Number6249442
OTHER Device ID Number00811806010861
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/15/2017
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: 04/16/2018 Patient Sequence Number: 1
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