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

Model Number	G22107
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
This file is being reported based on the fda mdr malfunction precedence "stent fracture".The gpso-5-3 couldn't get in the pancratic duct because the gpso-5-3 distal flap was broken.
Event or Problem Description
This file is being reported based on the fda mdr malfunction precedence "stent fracture".The gpso-5-3 couldn't get in the pancratic duct because the gpso-5-3 distal flap was broken.
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to (b)(4).Importer site establishment registration number: 3005580113.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Cook medical incorporated (cmi), 1025 acuff road, p.O box 4195, bloomington, indiana 47402-4195.Importer site establishment registration number: 3005580113.Device evaluation: 1 x gpso-5-3 device of lot c1512248 was returned to cirl for a lab evaluation.It was returned opened in it¿s original packaging.Lab evaluation: the device involved in the complaint was evaluated in laboratory on 3rd of december 2018.In summary the following results were observed in the lab evaluation.All of the stent was there in one piece, no defects found.There were no defects observed on the stent.Complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.Root cause (possible): no defect was identified with the stent.Complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.The reason given by the user that they could not advance the stent due to missing flaps on distal end would not cause advancement difficulties as the flaps have no impact on how the stent advances over the wire.However, the issue the user experience with advancement difficulties could have been due to an incorrect stent selection.The physician may have chosen a stent that was too short for the duct.See attached email from engineering ¿pr244596_engineering input¿.Documents review: the instructions for use, ifu (ifu0055-3) which accompanies this device instructs the end user to ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use¿.The instructions for use, ifu (ifu0055-3) which accompanies this device cautions the end user to ¿complete diagnostic evaluation must be performed, prior to use, to determine proper stent size.¿ summary: complaint is confirmed based on customer testimony.The patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for emerging trends.
Event or Problem Description
The gpso-5-3 couldn't get in the pancratic duct because the gpso-5-3 distal flap was broken.
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Cook medical incorporated (cmi), 1025 acuff road, p.O box 4195, bloomington, indiana 47402-4195.Importer site establishment registration number: (b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
The gpso-5-3 couldn't get in the pancratic duct because the gpso-5-3 distal flap was broken.

• Brand Name: GEENEN PANCREATIC STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8105123
• Report Number: 3001845648-2018-00551
• Device Sequence Number: 2118782
• Product Code: FGE
• UDI-Device Identifier: 00827002221079
• UDI-Public: (01)00827002221079(17)210619(10)C1512248
• Combination Product (Y/N): N
• PMA/510(K) Number: K900923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/16/2019

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: 06/19/2021
• Device Model Number: G22107
• Device Catalogue Number: GPSO-5-3
• Device Lot Number: C1512248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/27/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 10/31/2018; 10/31/2018; 10/31/2018
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 12/19/2018; 01/16/2019; 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1