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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ATRIUM ICAST COVERED STENTS; PROSTHESIS, TRACHAEL, EXPANDABLE
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ATRIUM MEDICAL CORP. ATRIUM ICAST COVERED STENTS; PROSTHESIS, TRACHAEL, EXPANDABLE Back to Search Results
Model Number 85419
Device Problems Material Separation (1562); Malposition of Device (2616)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/20/2014
Event Type  Injury  
Event Description
It was reported that after deployment of the stent the device was pulled back into the sheath and during removal the hub of the catheter separated from the shaft.The physician was successful in removing the remaining catheter and balloon intact from the sheath.No harm came to the patient.
 
Manufacturer Narrative
On completion of the evaluation a follow up report will be submitted.
 
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Brand Name
ATRIUM ICAST COVERED STENTS
Type of Device
PROSTHESIS, TRACHAEL, EXPANDABLE
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH 03051
Manufacturer Contact
lynda mclaughlin
5 wentworth dr.
hudson, NH 03051
6038645470
MDR Report Key4218784
MDR Text Key21492796
Report Number1219977-2014-00363
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 10/21/2014
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 Expiration Date01/31/2015
Device Model Number85419
Device Catalogue Number85419
Device Lot Number10818980
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/20/2014
Initial Date FDA Received10/30/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
TERUMO DESTINATION SHEATH 7FR 90 CM
Patient Outcome(s) Required Intervention;
Patient Age78 YR
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