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

Model Number	G22107
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/29/2017
Type of Reportable Event	Serious Injury
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 pending.A follow up mdr will be submitted with the investigation conclusions.
Event or Problem Description
Stent broken."as per complaint form: in (b)(6) 2017, the stent was implanted by the same hospital and physician.On the (b)(6) the stent should be removed.Stent was in an optimal position, but completely discoloured dark.When removing, the part of the stent was in the duodenum, fell apart into the smallest pieces.Rest piece without harm was in the pancreatic duct.
Additional Manufacturer Narrative
(b)(4).Exemption number: e2016031.Importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Problem statement: the customer reported the following complaint issue "stent broken "as per complaint form: in (b)(6) 2017, the stent was implanted by the same hospital and physician.On the (b)(6) the stent should be removed.Stent was in an optimal position, but completely discoloured dark.When removing, the part of the watch was in the duodenum, fall a parted into the smallest pieces.Rest piece without harm was in the pancreatic duct." additional information 09th sept 2017; was part of device left inside patient? no, all parts could be removed from the patient what was used to remove the stent? with a forceps.Lab evaluation: 1 x gpso-5-3 device was returned to cirl for evaluation.A lab evaluation was held on 21 sept 2017.Upon evaluation of the returned device it was noted that the returned piece of the stent was the ductal end.Therefore, the part of the stent in the patient must have been the duodenal end.The stent may have possibly been placed upside down.The stent discolouration is likely due to exposure in a gastric environment.The damage on the shaft is consistent with stent removal.Root cause: a definitive root cause for this complaint cannot be conclusively determined as the operational conditions cannot be replicated in a laboratory setting.However, a possible cause for this stent damage could be due to the stent removal method.Ifu review: it may be noted that according to the instructions for use, the user is instructed to visually inspect the device ¿if any abnormality is detected that would prohibit proper working condition, do not use¿.Fqc review: prior to distribution all geenen pancreatic devices are subject to visual inspection to ensure device integrity.These inspections are outlined in internal procedures in place at cook ireland.Document review: a review of the manufacturing records for the biliary stent device of lot c1314154 did not reveal any discrepancy related to the complaint issue.Summary: this complaint is confirmed as the stent was found to be damaged.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
This follow up mdr is being submitted to include the investigation conclusions.Stent broken."as per complaint form: in (b)(6) 2017, the stent was implanted by the same hospital and physician.On the (b)(6) the stent should be removed.Stent was in an optimal position, but completely discoloured dark.When removing, the part of the stent was in the duodenum, fell apart into the smallest pieces.Rest piece without harm was in the pancreatic duct.

• 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: 6917313
• Report Number: 3001845648-2017-00427
• Device Sequence Number: 19163622
• Product Code: FGE
• UDI-Device Identifier: 00827002221079
• UDI-Public: (01)00827002221079(17)200112(10)C1314154
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: G22107
• Device Catalogue Number: GPSO-5-3
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/05/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention