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

Model Number	G25673
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
User detected the pusher cannot be put through stent at preparation stage.No use on patient.N/a ¿ this observation was made prior to patient contact.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Supplemental follow-up report is being submitted due to the receipt and evaluation of the complaint device.Lab complete (b)(6) 2022.Visual inspection: stent with pigtail straightener, purple pushing catheter and black guiding catheter returned.Guiding catheter loaded on pushing catheter, all white hubs present.No visual damage noted on pushing catheter and guiding catheter or stent.Functional inspection: 0.035" wire guide passes through the stent.Guiding catheter moves freely through the pushing catheter.Stent can be deployed with the guiding catheter.
Event or Problem Description
Supplemental follow-up report is being submitted as a cancellation report following the completion of the investigation on 12-oct-2022.The event does no loner meets the criteria of an fda ¿serious injury¿ report or "malfunction¿" report as per fda guidelines medical device reporting for manufacturers (2016).
Additional Manufacturer Narrative
Supplemental follow-up report is being submitted as a cancellation report following the completion of the investigation on 12-oct-2022.The event does no longer meet the criteria of an fda "serious injury" report or "malfunction" report as per fda guidelines medical device reporting for manufacturers (2016).

• 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; holstein campus kiel; arnold- keller str- 3
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3
• MDR Report Key: 14712492
• Report Number: 3001845648-2022-00362
• Device Sequence Number: 5074304
• Product Code: FGE
• UDI-Device Identifier: 10827002256733
• UDI-Public: (01)10827002256733(17)240125(10)C1795026
• 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): 10/12/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2024
• Device Model Number: G25673
• Device Catalogue Number: ZSS-10-7-RB
• Device Lot Number: C1795026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 05/23/2022; 05/23/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 09/09/2022; 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2021
• 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
• Patient Sex: Unknown