MAUDE Adverse Event Report: COOK IRELAND LTD JOHLIN PANCREATIC WEDGE STENT; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G26831
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Reported by the dm on behalf of the customer- while performing an ercp trying to place the stent using a short wire and when attempting to pull the wire back the white part of the guiding catheter became disconnected and tore.Then while trying to deploy the stent the guiding catheter stretched out appearing melted and they were eventually able to place the stent and detach the deploying system.The inner guiding catheter part is stretched and coiled in some places as well.
Additional Manufacturer Narrative
Device evaluation: 1 x jpws-8.5-20 of lot number c1663184 was returned to cirl open in its original packaging.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 10th april 2020.The wire guide was returned stuck on the catheter, the black guiding catheter was very crumpled and jammed up against hub.The pushing catheter (purple) was detached from the hub.It was very damaged from where the hub should be to approx.37cm.A functional inspection was unable to be performed due to the damage and wire guide.The wire guide returned appeared to be a 0.025¿ but was confirmed as a 0.035.¿ image review: n/a.Documents review including ifu review: prior to distribution all jpws-8.5-20 are subjected to visual and functional checks to ensure device integrity.A review of the manufacturing records for jpws-8.5-20 of lot number c1663184 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1663184.The instructions for use, (b)(4) which accompanies this device instructs the user to ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ it should be noted that the device was used off-label, outside its intended use stated in the instructions for use (ifu) "this device is used to drain obstructed pancreatic ducts" and in the notes section ¿do not use this device for any purpose other than stated intended use.¿ where the use of a jpws-8.5-20 in the bile duct in this instance is not a stated use as per the ifu and therefore has not being tested in a clinical setting.It also noted that that this stent was altered from 20 cm down to 17 cm.Root cause review: a definitive root cause can be attributed to the off-label use of the device, when the device is outside its stated intended use, it may lead to outcomes that were never intended to happen and were never studied.The noted damage can be attributed to additional resistance on removal of guiding catheter in bile duct due to more acute angle.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the information reported, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
This follow up is being submitted due to the completion of the investigation.

• Brand Name: JOHLIN PANCREATIC WEDGE STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9883768
• Report Number: 3001845648-2020-00169
• Device Sequence Number: 2794651
• Product Code: FGE
• UDI-Device Identifier: 10827002268316
• UDI-Public: (01)10827002268316(17)221025(10)C1663184
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K990130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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: 10/25/2022
• Device Model Number: G26831
• Device Catalogue Number: JPWS-8.5-20
• Device Lot Number: C1663184
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/24/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 07/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1