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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED; MQR STENT, COLONIC METALLIC EXPANDABLE
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COOK IRELAND LTD EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED; MQR STENT, COLONIC METALLIC EXPANDABLE Back to Search Results
Model Number G48028
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/26/2020
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k) #: k163468.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
User advanced the device about 30cm and saw the space-occupying lesion which block the lumen.User changed endoscopy to continue the procedure but still cannot advance the device.User then tried using angiography catheter with wire guide to pass through the block area but failed.User cannot release the stent by pulling trigger.Was the directional button fully engaged? yes.Did the red indicator move when the trigger was pressed? no.Did the red indicator continue to move after the delivery stopped? stent was not released.Were any cracking/popping sounds heard from the handle? no.Was the stent partially exposed? no.If the stent was partially exposed, was it possible to recapture the stent fully before removal? stent was not partially exposed.Were any additional procedures needed? no.What is the patient outcome? patient was discharged by hospital already.
 
Manufacturer Narrative
Event was previously reported based on the device malfunction reporting precedence for this device family for the issue of ¿flexor kinked/stretched/broken/compressed¿.Device evaluated on (b)(6) 2020 " shuttle cap broken".Event no longer meets the requirements of a malfunction report based on the low risk assigned to a shuttle cap break.This report is being submitted as a cancellation report.Pma/510(k) #: k163468.
 
Event Description
Event was previously reported based on the device malfunction reporting precedence for this device family for the issue of ¿flexor kinked/stretched/broken/compressed¿.Device evaluated on (b)(6) 2020 " shuttle cap broken".Event no longer meets the requirements of a malfunction report based on the low risk assigned to a shuttle cap break.This report is being submitted as a cancellation report.User advanced the device about 30cm and saw the space-occupying lesion which block the lumen.User changed endoscopy to continue the procedure but still cannot advance the device.User then tried using angiography catheter with wire guide to pass through the block area but failed.User cannot release the stent by pulling trigger.1.Was the directional button fully engaged? yes.2.Did the red indicator move when the trigger was pressed? no.3.Did the red indicator continue to move after the delivery stopped? stent was not released.4.Were any cracking/popping sounds heard from the handle? no.5.Was the stent partially exposed? no.6.If the stent was partially exposed, was it possible to recapture the stent fully before removal? stent was not partially exposed.7.Were any additional procedures needed? no.8.What is the patient outcome? patient was discharged by hospital already.
 
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Brand Name
EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
Type of Device
MQR STENT, COLONIC METALLIC EXPANDABLE
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key10905919
MDR Text Key239583390
Report Number3001845648-2020-00890
Device Sequence Number1
Product Code MQR
UDI-Device Identifier10827002480282
UDI-Public(01)10827002480282(17)210808(10)C1638976
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberG48028
Device Catalogue NumberEVO-25-30-8-C
Device Lot NumberC1638976
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/26/2020
Event Location Hospital
Date Manufacturer Received10/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age79 YR
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