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

Model Number	G21438
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Dr.(b)(6) tried to insert a plastic stent, but the stricture was too tight.So the stent was kinked.Dr.(b)(6) used sbdc and hurricane balloon for dilation.After that, the plastic stent was inserted again.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent kinked/bent'.No adverse effects to the patient have been reported as occurring.
Event or Problem Description
(b)(6) tried to insert a plastic stent, but the stricture was too tight.So the stent was kinked.(b)(6) used sbdc and hurricane balloon for dilation.After that, the plastic stent was inserted again.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent kinked/bent'.No adverse effects to the patient have been reported as occurring.
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).Device evaluation: 1 x ttso-10-7 device of lot # c1509522 was returned to cirl for evaluation open in its original packaging.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 28th march 2019.The returned device lab findings and observations can be referred through the attached files.An indentation was observed at the ductal end of the stent, possibly due to removal.Document review including ifu review: prior to distribution ttso-10-7 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-10-7 of lot number c1509522 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 c1509522.As per instructions for use, ifu0045-6, a contraindications identified includes an ¿inability to pass wireguide or stent through obstructed area.¿ the user is also instructed to: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use¿ and ¿do not use this device if stent cannot advance through stricture area¿ root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.However, as per information provided, ¿the stricture was too tight.So the stent was kinked¿, a smaller or firmer stent may have been more appropriate for the stricture.The physician was eventually able to place the stent after the stricture was dilated.Summary: complaint is confirmed based on customer testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.According to the initial reporter, 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: 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: 8459163
• Report Number: 3001845648-2019-00120
• Device Sequence Number: 11527323
• Product Code: FGE
• UDI-Device Identifier: 00827002214385
• UDI-Public: (01)00827002214385(17)210612(10)C1509522
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 03/28/2019

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: 06/12/2021
• Device Model Number: G21438
• Device Catalogue Number: TTSO-10-7
• Device Lot Number: C1509522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/25/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1