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

Catalog Number	EVO-10-11-4-B
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing records for the evo-10-11-4-b device of lot number c1167106 revealed no discrepancies that could have contributed to this complaint issue.Prior to distribution, all evo-10-11-4-b devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.From the information provided there were no adverse effects to the patient due to this occurrence.Complaints of this nature will continue to be monitored for emerging trends.
Event or Problem Description
When the user was initially deploying the evolution biliary stent, the nurse pulled the safety wire from the device (at beginning of procedure).The stent deployed fine but when the physician wanted to retract for repositioning, the stent would not retract.They removed the stent and successfully completed the procedure with a new stent.The staff has since been re-inserviced on the device.Event meets fda mdr reporting criteria based on the malfunction precedence for this device family for 'a deployment issue resulting in the exposed stent being removed from the patient with the delivery system'.
Additional Manufacturer Narrative
Upon evaluation of the returned device it was noted that the safety wire was partially removed from the device.Damage to the flexor was noted.The cirl research & development engineer commented that the compression and damage evident to the flexor would have occurred as a result of the lockwire being pulled too soon.The handle was actuated and no issue was noted.The stent deployed fully.As per the information provided, the nurse pulled the safety wire from the device (at beginning of procedure).The staff has since been re-inserviced on the device.Also, following device evaluation, the (b)(4) research and development engineer has commented that the root cause of this complaint is user error - lockwire was released prematurely.Therefore, the information provided combined with the evaluation of the returned device confirmed user error.The customer complaint was confirmed based on the information provided and the evaluation of the returned device which both signified user error.The instructions for use states the following: ¿when stent point-of-no-return has been passed, disconnect luer lock fitting and remove safety wire completely from delivery handle¿ prior to distribution, all evo-10-11-4-b devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at (b)(4).A review of the manufacturing records for the evo-10-11-4-b device of lot number c1167106 revealed no discrepancies that could have contributed to this complaint issue.From the information provided there were no adverse effects to the patient due to this occurrence.Complaints of this nature will continue to be monitored for emerging trends.
Event or Problem Description
This follow up report is being submitted due to the receipt and evaluation of the device involved in this event.Initial description submitted as follows: when the user was initially deploying the evolution biliary stent, the nurse pulled the safety wire from the device (at beginning of procedure).The stent deployed fine but when the physician wanted to retract for repositioning, the stent would not retract.They removed the stent and successfully completed the procedure with a new stent.The staff has since been re-inserviced on the device.Event meets fda mdr reporting criteria based on the malfunction precedence for this device family for 'a deployment issue resulting in the exposed stent being removed from the patient with the delivery system'.

• Brand Name: EVOLUTION® BILIARY 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: 5469631
• Report Number: 3001845648-2016-00060
• Device Sequence Number: 13528255
• Product Code: FGE
• UDI-Device Identifier: 10827002231273
• UDI-Public: (01)10827002231273(17)171030(10)C1167106
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2016

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 Catalogue Number: EVO-10-11-4-B
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/01/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2016
• Supplement Report FDA Received Date: 03/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1