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

Catalog Number	GPSO-5-7
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1 device of gpso-5-7 lot number c1108774 was not returned to cirl for evaluation.As the device has not been returned the cause of the complaint could not be conclusively determined.As we cannot replicate the clinical conditions ,patients anatomy or use conditions we can not conclusively determine the root cause of the complaint.The customer complaint was confirmed based on the customers¿ testimony.Document review a review of the manufacturing records for the gpso-5-7 device involved in this complaint did not reveal any discrepancies related to the complaint issue a review of manufacturing records of component lot numbers revealed no discrepancies related to complaint issue prior to distribution, gpso-5-7 devices are subjected to visual inspection and functional checks to ensure device integrity.According to the instructions for use, the user is advised as follows: "if the package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".The precaution section of ifu states that "this device should not be left indwelling for more than three months or as directed by a physician.Periodic evaluation is recommended".In the potential complications section of ifu it also states ¿those associated with ercp include, but are not limited to: pancreatitis ¿ the cause of the complaint could not be conclusively determined.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
During an ercp dr.(b)(6) was placing a gpso in the pancreatic duct to prevent a post ercp pancreatitis.4 days after the pancreatic stent was removed the patient got an acute pancreatitis.The patient had severe pancreatitis with prolonged hospitalization, development of a relative stenosis of the bile duct and the pancreatic duct in the pancreatic head swelling and relative duodenal stenosis.
Additional Manufacturer Narrative
A 1 device of gpso-5-7 lot number c1108774 was not returned to (b)(4) for evaluation.As the device has not been returned a document based evaluation was carried out.The root cause of this complaint was conclusively determined - per ifu, the intended use of the geenan pancreatic stents is: this device is use to drain obstructed pancreatic ducts.Per complaint description: ¿dr.(b)(6) was placing a gpso in the pancreatic duct to prevent a post ercp pancreatitis¿ which is a prophylactic action.The duct was not obstructed prior to stent placement, therefore this stent was used for an off-label indication." a review of the manufacturing records for the gpso-5-7 device involved in this complaint did not reveal any discrepancies related to the complaint issue a review of manufacturing records of component lot numbers revealed no discrepancies related to complaint issue prior to distribution, gpso-5-7 devices are subjected to visual inspection and functional checks to ensure device integrity.According to the instructions for use, the user is advised as follows: "if the package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".The precaution section of ifu states that "this device should not be left indwelling for more than three months or as directed by a physician.Periodic evaluation is recommended".In the potential complications section of ifu it also states ¿those associated with ercp include, but are not limited to: pancreatitis ¿ the cause of the complaint could be conclusively determined as off label use.
Event or Problem Description
This follow up report is being submitted due to a re-review of the complaint information and the determination of a root cause.Initial event description submitted as follows: during an ercp dr.(b)(6) was placing a gpso in the pancreatic duct to prevent a post ercp pancreatitis.4 days after the pancreatic stent was removed the patient got an acute pancreatitis.The patient had severe pancreatitis with prolonged hospitalization, development of a relative stenosis of the bile duct and the pancreatic duct in the pancreatic head swelling and relative duodenal stenosis.

• 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: 5436083
• Report Number: 3001845648-2016-00036
• Device Sequence Number: 508381
• Product Code: FGE
• UDI-Device Identifier: 00827002221130
• UDI-Public: (01)00827002221130(17)180508(10)C1108774
• 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
• Report Date (Section B): 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: GPSO-5-7
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2016
• Supplement Report FDA Received Date: 03/11/2016
• 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