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

Model Number	G22163
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2018
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
Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent kinked bent' and 'difficult advancement'.Before using this product for procedure, the side hole of this product pigtail was "kink".The wire guide could not get into the zso-7-5.
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 (b)(4).Importer site establishment registration number: (b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
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
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
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 the zso-7-5 device of lot number c1513957 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation the device related to this occurrence underwent a laboratory evaluation on the 01st february 2019.Forceps marks and residue inside the stent were observed during the evaluation which suggest that the stent was used.A 0.035¿ wire guide was passed without issue.No kinks were observed on the stent.The pigtail straightener was not returned with the device.Document review prior to distribution zso-7-5 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.As per step 3 in final quality control, the manufacturing team member (mtm) is instructed to "inspect for debris in or on product, kinks".Additionally, in step 9, the manufacturing team member (mtm) is instructed to ¿verify size of wire guide before each use.Insert wire guide into both ends of stent.¿ a review of the manufacturing records for zso-7-5 of lot number c1513957 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 c1513957.It should be noted that the instructions for use (ifu0045-6) 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.¿ ¿care must be exercised when straightening the pigtail curls in order to avoid kinking or breaking the stent.¿ root cause review 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.It should be noted that that a 0.025¿ wireguide was used however a 0.035¿ wireguide is recommended as per the product label, it is possible that this negatively affected the ability to pass the stricture as a 0.025¿ wireguide would not offer as much support as a larger 0.035¿ wireguide.Summary the complaint is confirmed based on customer testimony.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: ZIMMON BILIARY STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8273794
• Report Number: 3001845648-2019-00027
• Device Sequence Number: 11077589
• Product Code: FGE
• UDI-Device Identifier: 00827002221635
• UDI-Public: (01)00827002221635(17)210625(10)C1513957
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2019

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: 06/25/2021
• Device Model Number: G22163
• Device Catalogue Number: ZSO-7-5
• Device Lot Number: C1513957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/21/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 12/28/2018; 12/28/2018
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 02/20/2019; 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1