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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ATRIUM ICAST COVERED STENT; PTFE COVERED STENT
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ATRIUM MEDICAL CORPORATION ATRIUM ICAST COVERED STENT; PTFE COVERED STENT Back to Search Results
Model Number 85420
Device Problem Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Date 08/31/2016
Event Type  Injury  
Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
 
Event Description
After deploying the stent successfully in the subclavian artery, while removing the catheter from the patient, the balloon came off the catheter in the sheath on exit.
 
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Brand Name
ATRIUM ICAST COVERED STENT
Type of Device
PTFE COVERED STENT
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
5 wentworth drive
hudson NH 03051
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
5 wentworth drive
hudson NH 03051
Manufacturer Contact
lynda mclaughlin rn, ccrn-k
40 continental blvd
merrimack, NH 03054
6038645470
MDR Report Key5946498
MDR Text Key54577789
Report Number1219977-2016-00192
Device Sequence Number1
Product Code JCT
UDI-Device Identifier00650862854206
UDI-Public00650862854206
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,health
Reporter Occupation Health Professional
Type of Report Initial
Report Date 08/31/2016
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 Date07/06/2019
Device Model Number85420
Device Catalogue Number85420
Device Lot Number240715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/31/2016
Initial Date FDA Received09/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/06/2016
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) Required Intervention;
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