MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Model Number	G48028
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: k163468.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Complaint called in by dm on (b)(6) 2019--did (b)(6) 2019.As reported to customer relations: "the stent would not deploy.The customer activated the trigger but it didn't deploy.Customer used another of the same gpn to complete the procedure." should be received at cadc 2 weeks from date of reporting (as dm is unable to get return sooner.Possibly vacation-related).Additional information provided by dm on (b)(6) 2019: "the red button was engaged for deployment but the stent would not deploy.There was no cracking or noise.They don't remember if the red indicator moved or not.The stent was not deployed but it seems to have been recaptured somehow as the tip of the introducer is slightly backed up within the catheter.".
Additional Manufacturer Narrative
Pma/510(k) #: k163468.This report is being submitted as a cancellation report.From the initial information received, this event was cautiously made reportable based on the precedence in place for this device of 'flexor kinked/stretched/broken/compressed'.However, when the returned device was received it was confirmed during the lab evaluation that this malfunction did not occur.Overall risk associated with the failure observed in the laboratory evaluation, shuttle cap break, overall risk is assessed as low.Low risk indicates no potential for serious injury if the malfunction were to recur.No reporting malfunction precedence exists for this complaint event for this product family.
Event or Problem Description
This report is being submitted as a cancellation report.From the initial information received, this event was cautiously made reportable based on the precedence in place for this device of 'flexor kinked/stretched/broken/compressed'.However, when the returned device was received it was confirmed during the lab evaluation that this malfunction did not occur.Overall risk associated with the failure observed in the laboratory evaluation, shuttle cap break, overall risk is assessed as low.Low risk indicates no potential for serious injury if the malfunction were to recur.No reporting malfunction precedence exists for this complaint event for this product family.Complaint called in by dm on 13sep2019--did 13sep2019.As reported to customer relations: "the stent would not deploy.The customer activated the trigger but it didn't deploy.Customer used another of the same gpn to complete the procedure." additional information provided by dm on 04oct2019: "the red button was engaged for deployment but the stent would not deploy.There was no cracking or noise.They dont remember if the red indicator moved or not.The stent was not deployed but it seems to have been recaptured somehow as the tip of the introducer is slightly backed up within the catheter.".

• Brand Name: EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9176912
• Report Number: 3001845648-2019-00518
• Device Sequence Number: 16670472
• Product Code: FGE
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)201119(10)C1560366
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2020
• Device Model Number: G48028
• Device Catalogue Number: EVO-25-30-8-C
• Device Lot Number: C1560366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/11/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1