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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 PFO OCCLUDER
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 10/19/2020
Event Type  Injury  
Manufacturer Narrative
Further information regarding this event has been requested. If returned, investigation results will be provided in a subsequent submission.
 
Event Description
On (b)(6) 2020 a 25mm amplatzer pfo occluder was implanted. On (b)(6) 2020 the patient became hypotensive post procedure. The patient complained of abdominal pain. In stat ct acute hemorrhage was observed. The patient was taken for an emergent repair of common femoral vein injury and inferior epigastric artery. The patient was reported to be in stable condition.
 
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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 Key10845784
MDR Text Key217107204
Report Number2135147-2020-00488
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPFO OCCLUDER
Device Catalogue Number9-PFO-025
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 Received11/25/2020
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 Invalid Data

Patient Treatment Data
Date Received: 11/16/2020 Patient Sequence Number: 1
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