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

Catalog Number GPSO-3-4

Device Problems Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2022

Event Type  malfunction  

Event Description

When the customer tried to insert gpso-3-4, because of narrow p-duct, he felt it couldn¿t move forwardly.So he changed gpso-5-5 and the case finished.Note: incorrect wireguide size used with gpso-3-4 (roadrunner wire 0.018 inch was used).(b)(4) - difficult advancement of gpso-3-4 + user error and incorrect wireguide size used (roadrunner wire 0.018 inch was used); (b)(4) - difficult advancement of pc-3.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.Please indicate where the device was stored prior to use.It was stored in their own cabinet.What is the reorder number, outer diameter and length of the wire guide that was used with this device in this procedure? roadrunner wire was used in this case.Were previous procedures i.E.Sphincterotomy etc.Carried out prior to placing the device over the particular wire guide? if yes please indicate the procedure performed.No.Was the wire guide inspected for damage prior to use? no.Was the device at the centre of the complaint inspected for damage prior to use? no.Did the patient involved exhibit altered anatomy or tortuous anatomy? no.If not with the device in question, how was the procedure finished? they used gpso-5-5, as replaced gpso-3-4.Patient outcome: 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.Patient/event info - notes: please indicate where the device was stored prior to use.It was stored in their own cabinet.What is the reorder number, outer diameter and length of the wire guide that was used with this device in this procedure? roadrunner wire was used in this case.Were previous procedures i.E.Sphincterotomy etc.Carried out prior to placing the device over the particular wire guide? if yes please indicate the procedure performed.No.Was the wire guide inspected for damage prior to use? no.Was the device at the centre of the complaint inspected for damage prior to use? no.Did the patient involved exhibit altered anatomy or tortuous anatomy? no.If not with the device in question, how was the procedure finished?* they used gpso-5-5, as replaced gpso-3-4.

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted due to the completion of the investigation.It can be noted that the complaint description has been updated to remove the user error.The 0.018-inch wireguide used in this procedure is the recommended sized wireguide for use.

Manufacturer Narrative

Device evaluation: the gpso-3-4 stent of unknown lot number involved in this complaint was not available for evaluation.Lab evaluation: n/a.Image review: n/a.Document review including ifu: prior to distribution all gpso-3-4 devices are subjected to visual and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place in cirl.A review of the manufacturing records for the gpdo-3-4 device could not be completed as the lot number is unknown.The instructions for use, ifu0055-4 which accompanies this device instructs the user to ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ it should be noted that according to the instructions for use, ifu0055, the following scenario is contraindicated "inability to pass a wireguide or stent through the obstructed area".This complaint involves an inability to pass the stent through the stricture site.Additional information received confirmed that an 0.018 inch roadrunner was used with the replacement gpso-3-4.Root cause review: a definitive root cause could not be determined as the device was not returned for evaluation.A possible root cause may be attributed to patient anatomy; the customer mentions the narrow pancreatic duct which may have been an aggravating factor of the advancement difficulty experienced.Summary: complaint is based on customer testimony.According to the information reported, the patient did not experience any adverse effects due to this occurrence.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
• 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: 13472525
• MDR Text Key: 296242193
• Report Number: 3001845648-2022-00069
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: GPSO-3-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/05/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 02/07/2022
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1