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

Model Number	G22161
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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
When they are straightening the stent a wire will not pass through freely due to kinks in the stent.They are not sure if the whole batch is affected "as per complaint form": when straightening the stent a wire will not pass through freely due to kinks in stent.This is the second time with this type of stent this has occurred.Unfortunately the first one was discarded, we are not sure if the whole batch is affected : zimmon biliary stent, ref zso-7-4, lot no.C1546479.We have the faulty one in the office if you require it returned to be examined.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
When they are straightening the stent a wire will not pass through freely due to kinks in the stent.They are not sure if the whole batch is affected "as per complaint form": when straightening the stent a wire will not pass through freely due to kinks in stent.This is the second time with this type of stent this has occurred.Unfortunately the first one was discarded, we are not sure if the whole batch is affected : zimmon biliary stent, ref zso-7-4, lot no.C1546479.We have the faulty one in the office if you require it returned to be examined.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 (b)(4) (importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (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
When they are straightening the stent a wire will not pass through freely due to kinks in the stent.They are not sure if the whole batch is affected "as per complaint form": when straightening the stent a wire will not pass through freely due to kinks in stent.This is the second time with this type of stent this has occurred.Unfortunately the first one was discarded, we are not sure if the whole batch is affected: zimmon biliary stent, ref zso-7-4, lot no.C1546479.We have the faulty one in the office if you require it returned to be examined.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 to section g.1 as follows: importer site contact and address: ed sutkowski cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Device evaluation: please note there are two files open in relation to this complaint.For details of the second investigation, please refer to pr (b)(4).Pr (b)(4) was created to capture a similar event that occurred at the same facility some time before this complaint.The complaint facility did not report this event at the time of occurrence and discarded the complaint device.Cirl only became aware of this event when pr (b)(4) was logged and requested that an additional complaint file (pr (b)(4)) be opened to capture this event (ref.Att.'pr (b)(4)_manufacturer additional pr confirmation').The zso-7-4 device of lot number c1546479 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 09 may 2019.A kink was observed on the 04th porthole at the tapered end of the stent and on the 03rd and 05th portholes at the non-tapered end of the stent.The straightener was returned on the stent in the incorrect orientation.Document review prior to distribution zso-7-4 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 zso-7-4 of lot number c1546479 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 c1546479.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0045-6).It should be noted that the ifu states the following: ¿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 excessive force on the stent as it was straightened to be loaded onto the wire guide.It is possible that excessive force during straightening of the stent caused and/or contributed to the formation of kinks on the stent.Kinks on the stent would have prevented the wire guide from passing through the stent which would have prevented further use of and/or placement of the stent.Summary complaint is confirmed as the failure was verified 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.
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).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
When they are straightening the stent a wire will not pass through freely due to kinks in the stent.They are not sure if the whole batch is affected "as per complaint form": when straightening the stent a wire will not pass through freely due to kinks in stent.This is the second time with this type of stent this has occurred.Unfortunately the first one was discarded, we are not sure if the whole batch is affected :- zimmon biliary stent, ref zso-7-4, lot no.C1546479.We have the faulty one in the office if you require it returned to be examined.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.

• 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: 8431470
• Report Number: 3001845648-2019-00111
• Device Sequence Number: 1634113
• Product Code: FGE
• UDI-Device Identifier: 00827002221611
• UDI-Public: (01)00827002221611(17)211004(10)C1546479
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/14/2019

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: 10/04/2021
• Device Model Number: G22161
• Device Catalogue Number: ZSO-7-4
• Device Lot Number: C1546479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/19/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 02/19/2019; 02/19/2019; 02/19/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 04/16/2019; 05/14/2019; 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1