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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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ATRIUM MEDICAL; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Hematoma (1884); Unspecified Infection (1930); Thrombosis (2100)
Event Type  Injury  
Manufacturer Narrative
A complaint investigation was not able to be performed as no product code, lot number, or sample was provided.Per the article the use of trilaminate ptfe graft allowed early access, reduced need for temporary hemodialysis catheters, decreased overall graft complication rates and significantly improved 1-year patency.
 
Event Description
Received an article titled "traditional versus early-access grafts for hemodialysis access: a (b)(6) study." the article was to report on the safety and efficacy of the use a trilaminate ptfe vascular graft for early cannulation in hemodialysis.Per the study adverse events included: thrombosis, infection, graft hematoma, edema.
 
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Type of Device
PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
Manufacturer (Section D)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer Contact
40 continental blvd
merrimack, NH 03054
MDR Report Key7340985
MDR Text Key102457947
Report Number3011175548-2018-00262
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation Physician
Type of Report Initial
Report Date 03/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/21/2018
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) Required Intervention;
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