MAUDE Adverse Event Report: COOK IRELAND LTD OASIS ONE ACTION STENT INTRODUCTION SYSTEM; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G25380
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/23/2019
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
Complaint received from dm via e-mail on 05nov2019--did 05nov2019.As reported to customer relations: "i received a product complaint on 10/25 regarding our stent introducer in relation to a biliary procedure.Customer: (b)(6) hospital, c13117-0, (352) 751-8000.Contact: (b)(6), lpn (lead endoscopy technician).Gpn: g25380, lot c1629388.Description: during an ercp, the endoscopist and technician used a stent introducer to advance a plastic biliary stent into the working channel of a duodenoscope.Unknowingly, the stent introducer was advanced beyond the biopsy port and into the scope.Because the team were unaware of this, no attempt to retrieve the introducer was made.When the same scope was used for another procedure, it was discovered that the stent introducer was still inside the scope, and was advanced down and out of the scope by a new stent.The customer recommends that cook change the color of the stent introducer (it is currently black) or not include it at all in the stent set, as the customer states they typically do not use it.As far as i know, the patient has not been affected by this event." additional information provided by dm on 05nov2019: " what endoscope was involved? a duodenoscope.".
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Complaint received from dm via e-mail on 05nov2019--did 05nov2019.As reported to customer relations: "i received a product complaint on 10/25 regarding our stent introducer in relation to a biliary procedure.Customer: the (b)(6) hospital, c13117-0, (352) 751-8000.Contact: (b)(6) , lpn (lead endoscopy technician).Gpn: g25380, lot c1629388.Description: during an ercp, the endoscopist and technician used a stent introducer to advance a plastic biliary stent into the working channel of a duodenoscope.Unknowingly, the stent introducer was advanced beyond the biopsy port and into the scope.Because the team were unaware of this, no attempt to retrieve the introducer was made.When the same scope was used for another procedure, it was discovered that the stent introducer was still inside the scope, and was advanced down and out of the scope by a new stent.The customer recommends that cook change the color of the stent introducer (it is currently black) or not include it at all in the stent set, as the customer states they typically do not use it.As far as i know, the patient has not been affected by this event." additional information provided by dm on 05nov2019: " what endoscope was involved? a duodenoscope.".
Additional Manufacturer Narrative
Device evaluation: the oacl-10-7 device of lot number: c1629388 involved in this complaint was not available for return, therefore a document based investigation will be completed.This pr was created to capture the subsequent procedure that resulted in the introducer falling into the second patient.(b)(6) was created to capture the introducer advancing into the scope during the initial procedure.Lab evaluation: n/a.Image review: n/a.Documents review including ifu review: prior to distribution oacl-10-7 devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for oacl-10-7 of lot number: c1629388 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: c1629388.As per ifu0096-1 ¿if this package is opened or damaged when received do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit working condition do not use.¿ root cause review: it has been determined with input from engineering & medical advisory that there was no product defect that contributed to this incident.Summary: complaint is not confirmed as the failure could not be verified.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.
Event or Problem Description
Complaint received from dm via e-mail on 05nov2019--did 05nov2019.As reported to customer relations: "i received a product complaint on 10/25 regarding our stent introducer in relation to a biliary procedure.Customer: the (b)(6) hospital, (b)(6).Contact: (b)(6), lpn (lead endoscopy technician).Gpn: g25380, lot c1629388.Description: during an ercp, the endoscopist and technician used a stent introducer to advance a plastic biliary stent into the working channel of a duodenoscope.Unknowingly, the stent introducer was advanced beyond the biopsy port and into the scope.Because the team were unaware of this, no attempt to retrieve the introducer was made.When the same scope was used for another procedure, it was discovered that the stent introducer was still inside the scope, and was advanced down and out of the scope by a new stent.The customer recommends that cook change the color of the stent introducer (it is currently black) or not include it at all in the stent set, as the customer states they typically do not use it.As far as i know, the patient has not been affected by this event." additional information provided on 05nov2019."what endoscope was involved? a duodenoscope.".

• Brand Name: OASIS ONE ACTION STENT INTRODUCTION SYSTEM
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9358164
• Report Number: 3001845648-2019-00621
• Device Sequence Number: 10872249
• Product Code: FGE
• UDI-Device Identifier: 00827002253803
• UDI-Public: (01)00827002253803(17)220708(10)C1629388
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K851962
• 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,Followup
• Report Date (Section B): 02/27/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2022
• Device Model Number: G25380
• Device Catalogue Number: OACL-10-7
• Device Lot Number: C1629388
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/23/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 11/05/2019; 11/05/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/19/2019; 03/06/2020
• 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: Hospitalization; Required Intervention