MAUDE Adverse Event Report: COOK IRELAND LTD ST-2 SOEHENDRA TANNENBAUM BILIARY STENT; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G22292
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
The device was used for biliary stent placement.The target site was the lower bile duct, and the stent could reach there with a pusher.However, it could not be released.Therefore, another manufacture¿s device was used instead.Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿difficult advancement'.
Event or Problem Description
The device was used for biliary stent placement.The target site was the lower bile duct, and the stent could reach there with a pusher.However, it could not be released.Therefore, another manufacture¿s device was used instead.Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿difficult advancement'.
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
The device was used for biliary stent placement.The target site was the lower bile duct, and the stent could reach there with a pusher.However, it could not be released.Therefore, another manufacture¿s device was used instead.Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿difficult advancement'.
Additional Manufacturer Narrative
1 of ttso-8.5-5 lot # c1562160 was returned to cirl for evaluation open in its original packaging.Investigation pr280754 is linked this investigation pr280750.Pr280750 deals with the stent in the complaint while pr280754 deals with the introducer.The stent was found to be stuck on the guiding catheter.A knot was noted on the guiding catheter which was untangled and the device was able to function as intended and the stent was deployed.The knot was concluded to be added after the procedure as otherwise the wire guide would not have been loaded.Prior to distribution ttso-8.5-5 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for ttso-8.5-5 of lot number c1562160 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 c1562160.It should be noted that the instructions for use states the following: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use.¿ a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the use of a non-recommended wire guide with the device.As the smaller diameter 0.025¿ wire guide was used this would not have supplied sufficient support during advancement.It may be noted the device label indicates a 0.035¿ wire guide for use with this device and all simulated use testing to date has been completed using a 0.035¿ wire guide.Complaint is confirmed as the failure was verified in the laboratory.
Event or Problem Description
The device was used for biliary stent placement.The target site was the lower bile duct, and the stent could reach there with a pusher.However, it could not be released.Therefore, another manufacture¿s device was used instead.

• Brand Name: ST-2 SOEHENDRA TANNENBAUM BILIARY STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9279082
• Report Number: 3001845648-2019-00579
• Device Sequence Number: 2524805
• Product Code: FGE
• UDI-Device Identifier: 00827002222922
• UDI-Public: (01)00827002222922(17)211123(10)C1562160
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/05/2020

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: 11/23/2021
• Device Model Number: G22292
• Device Catalogue Number: TTSO-8.5-5
• Device Lot Number: C1562160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/08/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 10/10/2019; 10/10/2019; 10/10/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/04/2019; 01/02/2020; 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1