Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ICAST
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ATRIUM MEDICAL CORP. ICAST Back to Search Results
Model Number 85455
Device Problem Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/13/2014
Event Type  Injury  
Event Description
The physician was treating a left iliac thrombosis and stenosis in both the common and external iliac arteries.The stent was placed but would not expand with the inflation device.It is unk if the sheath had been brought back to leave the stent uncovered to allow it to expand.The stent was removed and another stent was placed the case was completed successfully.
 
Manufacturer Narrative
Awaiting the return of the device and additional information in order to perform the evaluation.A follow-up report shall be submitted upon completion of the device evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ICAST
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH
Manufacturer Contact
lori gosselin, sr specialits
5 wentworth dr.
hudson, NH 03051
6038801433
MDR Report Key3677230
MDR Text Key4254619
Report Number1219977-2014-00021
Device Sequence Number1
Product Code JCT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050814
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 01/21/2014
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 Health Professional
Device Model Number85455
Device Catalogue Number85455
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/21/2014
Initial Date FDA Received02/20/2014
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;
-
-