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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. HERO SUPER HERO; VASCULAR GRAFT

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MERIT MEDICAL SYSTEMS, INC. HERO SUPER HERO; VASCULAR GRAFT Back to Search Results
Catalog Number HERO1000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 07/01/2017
Event Type  Injury  
Manufacturer Narrative
The suspect device is not expected to return for evaluation.
 
Event Description
The account reports the hero graft was infected resulting in bacterial sepsis with vegetation around the catheter.The patient had the hero placed (b)(6) 2017.During a follow up visit the patient presented with signs of infection.The patient was treated with antibiotics and the hero was explanted on (b)(6) 2017.
 
Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed and the root cause could not be determined.A review of the complaint database was performed and no similar complaints for this lot number were found.A review of the device history record was performed and no exception documents were found.
 
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Brand Name
HERO SUPER HERO
Type of Device
VASCULAR GRAFT
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
1600 merit parkway
south jordan UT 94095
Manufacturer (Section G)
MERIT MEDICAL SYSTEMS, INC.
1600 merit parkway
south jordan UT 94095
Manufacturer Contact
casey hughes, ms, cqe, csqp
1600 merit parkway
south jordan, UT 94095
8012531600
MDR Report Key6835721
MDR Text Key84269709
Report Number1721504-2017-00164
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K124039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date04/30/2018
Device Catalogue NumberHERO1000
Device Lot NumberH1028856
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/31/2017
Supplement Dates Manufacturer Received09/08/2017
Supplement Dates FDA Received09/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/19/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
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