EVOLUTION? DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED G48027 EVO-22-27-12-D

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-15 for EVOLUTION? DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED G48027 EVO-22-27-12-D manufactured by Cook Ireland Ltd.

Event Text Entries

[142274587] 510(k) number: k163468. (b)(4). Investigation is still pending, a follow up mdr will be submitted including the investigation conclusions.
Patient Sequence No: 1, Text Type: N, H10


[142274588] As initially reported to customer relations: a patient of unknown age and gender underwent an upper endoscopy with placement of duodenal stent which the evolution duodenal controlled-release stent, g48027- qty. 2 were used. (an additional file has been created to capture the second device) both stents were prepped correctly. Both were passed down the scope. When asked to deploy, the trigger was squeezed and the little plastic piece moved down the handle, but the catheter did not move and the stent did not deploy. There was an audible click with the second stent. The position was good and scope was straight inside. Dr. Reported the scope was not looped tight on the outside. This is the message that was sent to me [district manager] from the nurse. The reference to the little plastic piece on the handle is the indicator for where they are in the deployment. The procedure was completed by using a third stent.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3001845648-2019-00145
MDR Report Key8514469
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-04-15
Date of Report2019-05-13
Date of Event2019-03-18
Date Facility Aware2019-03-19
Date Mfgr Received2019-03-20
Device Manufacturer Date2018-09-20
Date Added to Maude2019-04-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. HEATHER RYAN
Manufacturer StreetO HALLORAN ROAD NATIONAL TECHNOLOGY PARK
Manufacturer CityLIMERICK
Manufacturer Phone061334440
Manufacturer G1COOK IRELAND LTD
Manufacturer StreetO HALLORAN ROAD NATIONAL TECHNOLOGY PARK
Manufacturer CityLIMERICK
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEVOLUTION? DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
Generic NameMUM STENT, METALIC EXPANDABLE, DUODENAL
Product CodeMUM
Date Received2019-04-15
Returned To Mfg2019-04-16
Model NumberG48027
Catalog NumberEVO-22-27-12-D
Lot NumberC1541865
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age179 DA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOOK IRELAND LTD
Manufacturer AddressO HALLORAN ROAD LIMERICK


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.