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

Model Number	G22980
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Jaundice (2187)
Date of Event	09/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
User remove the stone by cholangiotomy and implant the stent in pancreas as drainage purpose.Patient had recurrent vomiting, abdominal pain, jaundice 3 days after stent implantation.User took some treatment to relieve the symptom but failed.User remove the stent by gastroscope and the abdominal pain and jaundice is relieved gradually.User investigate the case and conclude the reason is patient related, and patient had rejection reaction against stent.
Event or Problem Description
User remove the stone by cholangiotomy and implant the stent in pancreas as drainage purpose.Patient had recurrent vomiting, abdominal pain, jaundice 3 days after stent implantation.User took some treatment to relieve the symptom but failed.User remove the stent by gastroscope and the abdominal pain and jaundice is relieved gradually.User investigate the case and conclude the reason is patient related, and patient had rejection reaction against stent.
Additional Manufacturer Narrative
Device evaluation: the spsof-5-5 device of lot number c1389657 involved in this complaint was not available for return to cirl for evaluation.Therefore, a document-based investigation was conducted.Lab evaluation: n/a.Image review: n/a.Documents review including ifu review: prior to distribution spsof-5-5 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.A review of the manufacturing records for spsof-5-5 of lot number c1389657 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1389657.The instructions for use, ifu0055-3, which accompanies this device warns the user of the following potential complications ¿those associated with pancreatic stent placement include but are not limited to: trauma to the pancreatic tract or duodenum, obstruction of the common bile duct, stent migration.¿ several attempts were made to obtain additional information regarding the failure of this device.However, no response has been received to date.The investigation will be updated in the future if any additional information is received.There is not enough evidence to determine that the customer did or did not follow the instructions for use.The description of the complaint states ¿patient had recurrent vomiting, abdominal pain, jaundice 3 days after stent implantation¿.As per clinical input the jaundice experienced by the patient was an indication of a biliary reocclusion.Root cause (possible): a definitive root cause could not be determined from the available information.However, as per the instructions for use, obstruction of the common bile duct is a known potential complication.Summary: the complaint is confirmed based on the customer¿s testimony.According to the initial reporter, the user removed the stent by gastroscope and the abdominal pain and jaundice was relieved gradually.No further adverse effects have been reported.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZIMMON PANCREATIC STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9615597
• Report Number: 3001845648-2020-00046
• Device Sequence Number: 547655
• Product Code: FGE
• UDI-Device Identifier: 00827002229808
• UDI-Public: (01)00827002229808(17)200817(10)C1389657
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2020

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 Expiration Date: 08/17/2020
• Device Model Number: G22980
• Device Catalogue Number: SPSOF-5-5
• Device Lot Number: C1389657
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/14/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 08/06/2020
• 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
• Patient Age: 43 YR