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

Model Number	G22167
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Contact person: unknown.Complaint facility/organization name: (b)(6) hopstial.Entity id: (b)(6).Street: (b)(6).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
Uneven stent ends were observed before preloading the stent unto the pushing catheter, one loop was smaller than the other.The stent was then attempted to be preloaded unto the pushing catheter, however it was not able to be preloaded because there is a fold on the tapered end of the stent.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
Uneven stent ends were observed before preloading the stent unto the pushing catheter, one loop was smaller than the other.The stent was then attempted to be preloaded unto the pushing catheter, however it was not able to be preloaded because there is a fold on the tapered end of the stent.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
(b)(4).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-7-7 device of lot number c1423004 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 04th april 2019.Refer to attachments pr 257904_lab attendance and pr 257904_lab evaluation notes for lab attendance and notes.A kink was observed at the 02nd porthole on the tapered end of the stent.The non-tapered end of the stent looked unused.Document review prior to distribution zso-7-7 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 zso-7-7 of lot number c1423004 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 c1423004.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0045-6).However, 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 as the straightener was removed from the stent.Summary complaint is confirmed as the failure was verified in the laboratory.No adverse effects to the patient have been reported as a result of this event.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: 8522086
• Report Number: 3001845648-2019-00157
• Device Sequence Number: 16843688
• Product Code: FGE
• UDI-Device Identifier: 00827002221673
• UDI-Public: (01)00827002221673(17)201116(10)C1423004
• Combination Product (Y/N): N
• PMA/510(K) Number: K851962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

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: 11/16/2020
• Device Model Number: G22167
• Device Catalogue Number: ZSO-7-7
• Device Lot Number: C1423004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/17/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1