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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FCG KIT, NEEDLE, BIOPSY

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COOK IRELAND LTD EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FCG KIT, NEEDLE, BIOPSY Back to Search Results
Catalog Number EVO-FC-8-9-8-B
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/13/2018
Event Type  malfunction  
Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of (b)(4). Exemption number: (b)(4). Importer site contact and address: (b)(6). Importer site establishment registration number: (b)(4). Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
As per complaint form: upon deploying of the stent it did not open as it should be.
 
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Brand NameEVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
Type of DeviceFCG KIT, NEEDLE, BIOPSY
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
Manufacturer (Section G)
COOK IRELAND LTD
o halloran road
national technology park
limerick
Manufacturer Contact
heather ryan
o halloran road
national technology park
limerick 
061334440
MDR Report Key8027302
MDR Text Key125756037
Report Number3001845648-2018-00512
Device Sequence Number1
Product Code FCG
UDI-Device Identifier10827002231327
UDI-Public(01)10827002231327(17)191218(10)C1434720
Combination Product (y/n)N
PMA/PMN Number
K900923
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 12/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/18/2019
Device Catalogue NumberEVO-FC-8-9-8-B
Device Lot NumberC1434720
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/03/2018
Event Location Hospital
Date Manufacturer Received10/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/18/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/01/2018 Patient Sequence Number: 1
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