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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-ITV08F180/80
Device Problems Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); Cardiac Arrest (1762)
Event Date 09/28/2017
Event Type  Injury  
Manufacturer Narrative

Not returned.

 
Event Description

On (b)(6) 2017, a pda closure procedure was attempted. During the procedure, a 6 mm amplatzer duct occluder was unable to pass through a 6f and a 7f torqvue delivery system due to resistance which extended the procedure time. An 8f torqvue delivery system was substituted and upon crossing the pda with the 8f delivery system the patient experienced cardiac arrest and required resuscitation. The delivery system was removed and the case abandoned. Per report, the patient may be pda dependent and the patient anatomy may preclude closure of the ductus.

 
Event Description

On (b)(6) 2017, a pda closure procedure was attempted. During the procedure, a 6mm amplatzer duct occluder was unable to pass through a 6f and a 7f torqvue delivery system due to resistance which extended the procedure time. An 8f torqvue delivery system was substituted and upon crossing the pda with the 8f delivery system the patient experienced cardiac arrest and required resuscitation. The delivery system was removed and the case abandoned. Per report, the patient may be pda dependent and the patient anatomy may preclude closure of the ductus.

 
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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 Key6950876
MDR Text Key89366123
Report Number2135147-2017-00131
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeSF
PMA/PMN NumberK072313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Remedial Action Patient Monitoring
Type of Report Initial,Followup
Report Date 12/27/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/16/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device EXPIRATION Date10/31/2019
Device MODEL Number9-ITV08F180/80
Device Catalogue Number9-ITV08F180/80
Device LOT Number5732555
OTHER Device ID Number00811806010823
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/15/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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