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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMULET DELIVERY SHEATH 14F 80CM

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AGA MEDICAL CORPORATION AMULET DELIVERY SHEATH 14F 80CM Back to Search Results
Model Number DS-TV45X45-14F-080
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Air Embolism (1697); Death (1802); Ischemia (1942)
Event Date 02/08/2019
Event Type  Death  
Manufacturer Narrative

An event of an embolism, ischemia, 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 the user suspected a deep breath by the patient during the procedure pulled air into the device.

 
Event Description

On (b)(6) 2019, a 25mm amplatzer amulet was selected for implant using a 14fr amplatzer torqvue delivery system. The amulet was prepared and flushed, and as the device was inserted into the delivery system, the patient spontaneously took a deep breath. The user suspected the breath contributed to air pulled into the delivery system. The physician noticed the air in the delivery system and used a syringe to aspirate. Immediately, the patient became symptomatic and the patient was resuscitated after two and a half hours with the use of an impella device. The patient was stabilized in a critical state, and several hours following the procedure, the patient expired from ischemia of the right coronary artery following air embolism of the procedure. Per report, the syringe was not held upright to ensure no air was introduced back into the loader.

 
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Brand NameAMULET DELIVERY SHEATH 14F 80CM
Type of DeviceAMULET DELIVERY SHEATH 14F 80CM
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 Key8406513
MDR Text Key138343248
Report Number2135147-2019-00071
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeGM
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 03/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/10/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDS-TV45X45-14F-080
Device LOT Number6694025
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 Received02/08/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/16/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/10/2019 Patient Sequence Number: 1
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