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

Model Number	G21802
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
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
The user attempted to advance the stent over a wire guide (olympus' visiglide 0.025 inch) but could not since the stent had a kink.(pr357864).The user replaced it with another gpds-5-3(lot unknown) to complete the procedure.(pr357865).The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Lab evaluation date: 03 may 2022: visual inspection: kink observed on tapered end side of stent.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Device evaluation: 1 x gpds-5-3 of lot number c1895099 was returned to cirl for evaluation.This file captures a kinked stent due to user error of an incorrect sized wireguide used on the the original device.This file is related to (b)(4) (mdr ref: 3001845648-2022-00236) which captures user error due to an incorrect sized wireguide used on the replacement device.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 03 may 2022.The returned device lab findings and observations can be referred through the attached files.A kink was observed on tapered end side of stent.A 0.035 inch wire guide passes through.Documents review including ifu review: prior to distribution all gpds-5-3 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.The instructions for use, ifu0055-4 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.¿ a review of the manufacturing records for the gpds-5-3 device could not be completed as the lot number is unknown.There is evidence to suggest that the user did not follow the instructions for use.The japanese packaging insert (c-es0202m16) supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.Root cause review: a definitive root cause could be attributed to the use of a non-recommended wire guide with the device.It may be noted the device label indicates a 0.035¿ wire guide for use with this device and all simulated use testing to date has been completed using a 0.035¿ wire guide.As per information provided a 0.025" wireguide was used to place the stent.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
Report is is being submitted due to completion of the investigation.

• Brand Name: GEENEN PANCREATIC STENT SET
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3; limerick
• MDR Report Key: 14165677
• Report Number: 3001845648-2022-00235
• Device Sequence Number: 5011786
• Product Code: FGE
• UDI-Device Identifier: 00827002218024
• UDI-Public: (01)00827002218024(17)241208(10)C1895099
• Combination Product (Y/N): N
• PMA/510(K) Number: K900923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2022

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: 12/08/2024
• Device Model Number: G21802
• Device Catalogue Number: GPDS-5-3
• Device Lot Number: C1895099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/24/2022
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 03/25/2022; 03/25/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 06/01/2022; 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown