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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION FLIXENE GWT W/DBL GDS
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ATRIUM MEDICAL CORPORATION FLIXENE GWT W/DBL GDS Back to Search Results
Model Number 25135
Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Torn Material (3024)
Patient Problem No Code Available (3191)
Event Date 02/12/2014
Event Type  Injury  
Event Description
Physician was performing a replacement upper arm graft with flixene.Tunneler was advanced and slider was attached to tunneler and pulled through after graft was soaked in sterile saline.Once graft was in the body, the slider would not pull out.Slider sleeve ripped and dragged graft with it even with a vascular clamp in place.This caused a bad position of the anastomosis site and forced physician to re-do procedure.
 
Manufacturer Narrative
Upon completion of investigation a follow up report shall be submitted.
 
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Brand Name
FLIXENE GWT W/DBL GDS
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH
Manufacturer Contact
theresa morin, mgr
5 wentworth dr.
hudson, NH 03051
6038801433
MDR Report Key3700642
MDR Text Key4249796
Report Number1219977-2014-00103
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071923
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/31/2018
Device Model Number25135
Device Catalogue Number25135
Device Lot Number10920181
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/27/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/13/2014
Date Device Manufactured12/01/2013
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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