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

Catalog Number	GEPD-7-7
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The gepd-7-7 device off lot # c1181127 was returned to cirl for evaluation.On evaluation of returned device the device was confirmed broken as per customer complaint.The two separated components of the device was measured by r&d engineer and confirmed that all parts of the stent retrieved from the patient as initially reported.The device was broken at the weakest point of the stent at the flaps.The stent also appeared black in appearance.With the information provided the stent was not left in dwelling for more than 3 months and no resistance was met on retrieval of the stent.A definitive cause for the customer¿s complaint was unable to be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, cook ireland could not reproduce the actual conditions of device usage.A review of the manufacturing records for gepd-7-7 device of lot c1181127 did not reveal any discrepancies related to the complaint issue.Prior to distribution, gepd-7-7 devices are subjected to visual inspection and functional checks to ensure device integrity which are outlined in cirl internal procedures.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".The complaint was confirmed as the device was broken in two on evaluation of the returned device.There have been no adverse effects on the patient as a result of this occurrence.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
After placement of a pancreatic stent the physician wanted to take the stent out from the wirsung.She used a snare and placed it into the tabs, it didn't work, it was like the stent was impacted in the pancreas.The physician gripped the stent by the snare but there was a strong resistance while withdrawing the stent, which resulted in the stent breaking in half within the pancreas.Using a paediatrics biopsy, the doctor retrieved both parts of the stent from the patient.The patient is fine and returned home the next day.A section of the device did not remain inside the patient's body.

• Brand Name: GEENEN PANCREATIC STENT SET
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 5702858
• Report Number: 3001845648-2016-00151
• Device Sequence Number: 13506633
• Product Code: FGE
• UDI-Device Identifier: 00827002214798
• UDI-Public: (01)00827002214798(17)181209(10)C1181127
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2016

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 Catalogue Number: GEPD-7-7
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/09/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2016
• Initial Report FDA Received Date: 06/07/2016
• 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