MAUDE Adverse Event Report: COOK IRELAND LTD SOLUS BILIARY STENT AND INTRODUCER SET; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G25675
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
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
When the physician tried to insert zss-10-12, he couldn¿t deploy this stent because the stent migrated very fast.(user error: incorrect size wireguide used 0.025 inch) so removed the stent and used 7fr double-pigtail stent.Did any section of the device remain inside the patient body? no.Did the patient require any additional procedures due to this occurrence? no.Did the product cause or contribute to the need for additional procedure(s)? no.Were there any adverse effects on the patient due to this occurrence? no.Did the product cause or contribute to the adverse effect(s)? no.
Event or Problem Description
Note: incorrect wireguide size used lab evaluation (b)(6) 2022.Visual inspection: pushing catheter, guiding catheter , stent and radiopaque introducer all returned.Slight decolourisation noted on pigtail curls of stent.( appears to have been used ) no other defects noted.Functional inspection: stent deploys as expected.0.035 inch wire guide passes through freely.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Device evaluation: 1 x zss-10-12-rb of lot number cf1710596 was returned to cirl open in its original packaging.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on (b)(6) 2022.Pushing catheter, guiding catheter , stent and radiopaque introducer all returned.Slight decolourisation noted on pigtail curls of stent.( appears to have been used ).No other defects noted.The stent deploys as expected.0.035 inch wire guide passes through freely.Image review: n/a.Documents review including ifu review: prior to distribution all (b)(4) devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for the (b)(4) device 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 cf1710596.It should be noted that according to the instructions for use (ifu0100-1) that the potential complications associated with ercp "include, but are not limited to: pancreatitis, cholangitis, aspiration, perforation, hemorrhage, infection, sepsis, allergic reaction to contrast or medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.Additional complications associated with biliary stent placement include but are not limited to: trauma to the biliary tract or duodenum, obstruction of pancreatic duct, stent migration." there is no evidence to suggest that the user did not follow the instructions for use.Root cause review: a definitive root cause could not be determined as the circumstances of use could not be replicated in the laboratory.However, as per the instructions for use, migration is a known complication associated with the device.The user error of the incorrect sized wireguide used is secondary to the migration that occurred.Summary: complaint is confirmed based on customer and/or rep testimony.According to the information reported, the patient did not experience any adverse effects due to the migration.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation.

• Brand Name: SOLUS BILIARY STENT AND INTRODUCER SET
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 14787327
• Report Number: 3001845648-2022-00379
• Device Sequence Number: 14921918
• Product Code: FGE
• UDI-Device Identifier: 10827002256757
• UDI-Public: (01)10827002256757(17)230221(10)CF1710596
• Combination Product (Y/N): N
• PMA/510(K) Number: K851962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/21/2023
• Device Model Number: G25675
• Device Catalogue Number: ZSS-10-12-RB
• Device Lot Number: CF1710596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/24/2022
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2022
• Supplement Date Received by Manufacturer: 05/27/2022; 05/27/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 08/03/2022; 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown