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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aspiration/Inhalation (1725)

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Date aware: 01-nov-19.Country of origin: (b)(6).Device: unknown (5-fr pancreatic stent geenan).Brief description: aspiration pneumonia in the ps-wgc group event description: early pancreatic stent placement in wire-guided biliary cannulation: a multicenter retrospective study.Ps-wgc is pancreatic stent placement followed by wgc (guidewire insertion to a pancreatic duct under wire-guided cannulation).Pancreatic stent was immediately placed after guidewire insertion to the pancreatic duct in the ps-wgc group.A total of 590 patients (183 in the ps-wgc and 407 in the repeated wgc group) were included.In the ps-wgc group, a 5-fr pancreatic stent with an internal flange (advanix, boston scientific japan or geenen, cook japan, (b)(4)) was placed immediately after guidewire insertion to the pancreatic duct, followed by attempts of wgc alongside the pancreatic stent in situ.1 patient suffered aspiration pneumonia in the ps-wgc group.

Event Description

Date aware: (b)(6) 2019.Country of origin: japan.Device: unknown (5-fr pancreatic stent geenan).Brief description: aspiration pneumonia in the ps-wgc group.Event description: early pancreatic stent placement in wire-guided biliary cannulation: a multicenter retrospective study.Ps-wgc is pancreatic stent placement followed by wgc (guidewire insertion to a pancreatic duct under wire-guided cannulation ).Pancreatic stent was immediately placed after guidewire insertion to the pancreatic duct in the ps-wgc group.A total of 590 patients (183 in the ps-wgc and 407 in the repeated wgc group) were included.In the ps-wgc group, a 5-fr pancreatic stent with an internal flange (advanix, boston scientific japan or geenen, cook japan, tokyo, japan) was placed immediately after guidewire insertion to the pancreatic duct, followed by attempts of wgc alongside the pancreatic stent in situ.1 patient suffered aspiration pneumonia in the ps-wgc group.

Manufacturer Narrative

Device evaluation: n/a.Lab evaluation: n/a.Image review: n/a.Document review including ifu review: prior to distribution all geenen pancreatic stent 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 the geenen pancreatic stent device could not be complete as the lot number is unknown.As per instructions for use, ifu0055-4 which accompanies this device, potential complications section: ¿those associated with ercp include, but are not limited to: pancreatitis, cholangitis, aspiration, perforation, haemorrhage, infection, sepsis, allergic reaction to contrast or medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.Those associated with pancreatic stent placement include, but are not limited to: trauma to the pancreatic tract or duodenum, obstruction of the bile duct, stent migration.¿ root cause review: a definitive root cause could not be determined from the available information.However, cirl engineering & medical advisory agreed that the aspiration pneumonia was procedure related rather than device related.As per ifu, cholangitis is listed as a known potential complication associated with ercp.It may also be noted that these devices were used off-label, investigation for off-label is captured under separate files.Summary: complaint is not confirmed as it has been determined to be not device related.Patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: GEENEN PANCREATIC STENT
• Type of Device: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9391584
• MDR Text Key: 176110167
• Report Number: 3001845648-2019-00644
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• PMA/PMN Number: K900923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNONW
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention