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

Catalog Number	GPSOS-SF-5-3
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.
Event or Problem Description
The incorrect stent was inside packaging.The stent intended to be placed was a g49668 from lot number c1994025.However, the stent in the packaging has internal flanges (the product details are unknown at this time; the product is being returned for evaluation).
Event or Problem Description
Cancellation report is being submitted due to the completion of the investigation on 05-apr-2024.Fda mdr reporting not required: the event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿."product complaint is not confirmed: there is no verifiable failure identified with the device(s).Additional file (b)(4) to capture the previously reported damaged evaluated on the returned device and the stent removal.
Additional Manufacturer Narrative
Cancellation report is being submitted due to the completion of the investigation on 05-apr-2024.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.No risk is required where, "product complaint is not confirmed: there is no verifiable failure identified with the device(s).Additional file is opened (b)(4) to capture the stent damage returned for evaluation and the associated stent remove.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.Device evaluation: 1 unit of unknown lot number of unknown rpn was returned opened not in its original packaging.With the information provided, a physical examination and document based investigation was conducted.The outer packaging (rpn: gpsos-sf-5-3, lot number: c1994025) and inner packaging (rpn: gpsos-sf-5-3, lot number: c2002076) were returned opened and unsealed.The lot numbers that were observed on the packaging, c1994025 and c2002076, are unrelated to the stent that was returned containing 4 flaps, which appears to be a gpso-sf.The device involved in the complaint was evaluated in the laboratory on 17 aug 2023.The returned device lab findings and observations can be referred through the attached files.Visual inspection: stent returned, 4 flaps visible, one flap damaged and pushed in.Compression damage on stent.Functional inspection: n/a the returned device contained 4 flaps and is a geenen pancreatic stent with internal flap, possibly a gpso-sf.An additional file (b)(4) was opened to capture the damage observed on the returned stent.Clarification was requested from the customer as 2 different lot numbers were observed on the returned device.Lot number c2002076 was observed on the tyvek packaging and lot number c1994025 was observed on the outer packaging in which the device was returned.Reply received: "hi, from what i remember the incorrect package with a different lot number and g# was placed in a box.Nothing about the package and its contents matched the ordering description." manufacturing records: prior to distribution, all gpsos-sf-5-3 devices are subjected to functional checks and visual inspection to ensure device integrity.As per cirl instruction, the mtm is required to ¿complete a 100% visual inspection of a unit while held at a comfortable arm¿s length from the unaided eye at normal lighting conditions for all units in a reasonable amount of time.¿ as per cirl instruction, the mtm is to ¿verify number of flaps on stents if applicable.¿ a review of the manufacturing records for gpsos-sf-5-3 device of lot number c1994025 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: a review of the manufacturing records for the gpsos-sf-5-3 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 c1994025.Instructions for use and label: the notes section of the instructions for use (ifu0121), which accompanies this device instructs the user to inspect the device prior to use : "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".There is no evidence to suggest that the customer did not follow the instructions for use.(ifu0121) image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined from the information available.This complaint has been deemed not a reject based on confirmation received from production that both lot numbers were processed 2 weeks apart and placed on separate sterilisation loads in addition to checks being carried out at packaging and post-sterilisation which means that there is no possibility of an error occurring whereby both lots were packaged together and left the facility at cirl.Therefore , a possible root cause could be attributed to a mix up that may have occurred at the facility when the device was being handled or during device preparation which resulted in the tyvek pouch containing the stent being inadvertently placed in the incorrect packaging.This is reaffirmed by the returned device, containing separate lot numbers, which was opened and unsealed in the packaging.Confirmation of complaint: complaint cannot be confirmed because the failure could not be verified in the laboratory or on customer and/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: according to the customer, incorrect stent in packaging confirmed quantity of 1 device, confirmed used.According to the initial report, the patient did not experience any adverse effects due to this occurrence.Investigation findings conclude that a definitive root cause could not be determined from the information available.This complaint has been deemed not a reject based on confirmation received from production that both lot numbers were processed 2 weeks apart and placed on separate sterilisation loads in addition to checks being carried out at packaging and post-sterilisation which means that there is no possibility of an error occurring whereby both lots were packaged together and left the facility at cirl.Therefore , a possible root cause could be attributed to a mix up that may have occurred at the facility when the device was being handled or during device preparation which resulted in the tyvek pouch containing the stent being inadvertently placed in the incorrect packaging.This is reaffirmed by the returned device, containing separate lot numbers, which was opened and unsealed in the packaging.

• Brand Name: GEENEN SOF-FLEX PANCREATIC STENT
• 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: 17564539
• Report Number: 3001845648-2023-00638
• Device Sequence Number: 17808700
• Product Code: FGE
• UDI-Device Identifier: 10827002496689
• UDI-Public: (01)10827002496689(17)251101(10)C1994025
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K900923
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2024

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: 11/01/2025
• Device Catalogue Number: GPSOS-SF-5-3
• Device Lot Number: C1994025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/13/2023
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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