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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 Chest Pain (1776); Fever (1858); Hematoma (1884)
Event Date 08/14/2019
Event Type  Injury  
Manufacturer Narrative

Investigation results will be provided in a subsequent submission.

 
Event Description

On (b)(6) 2019, an amplatzer pfo occluder was implanted using a torque delivery system and the patient was discharged. On (b)(6) 2019, the patient was admitted for fever and chest pain. A right groin hematoma was discovered, the patient was treated with iv infusion antibiotics and discharged home. The patient is reported to be stable.

 
Manufacturer Narrative

An event of hematoma was reported. The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.

 
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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 Key9528823
MDR Text Key178356918
Report Number2135147-2019-00466
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
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 01/20/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2019
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 Received01/07/2020
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: 12/29/2019 Patient Sequence Number: 1
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