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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER® TORQVUE® (UNKNOWN) CATHETER, PERCUTANEOUS

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AGA MEDICAL CORPORATION AMPLATZER® TORQVUE® (UNKNOWN) CATHETER, PERCUTANEOUS Back to Search Results
Model Number CVD0111
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Cardiac Tamponade (2226)
Event Type  Death  
Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

 
Event Description

It was reported in a research article that a study was conducted from february 2016 to january 2019 where 527 patients were implanted with an amplatzer septal occluder and some experienced complications post-procedure. One patient underwent surgical drainage due to a large pericardial effusion that led to a tamponade after suffering a tear in the left upper pulmonary vein and left atrial junction. The patient expired the next day after the surgery. Manufacturer report numbers: 2135147-2020-00082; 2135147-2020-00083.

 
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Brand NameAMPLATZER® TORQVUE® (UNKNOWN)
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 Key9781558
MDR Text Key181820917
Report Number2135147-2020-00088
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeNP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCVD0111
Device Catalogue NumberCVD0111
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 Received03/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 03/03/2020 Patient Sequence Number: 1
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