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

Model Number	G21708
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2018
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.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Before using this product for procedure, the side hole of this product pigtail was kink.The wire guide could not get into the zso-7-12.
Event or Problem Description
Before using this product for procedure, the side hole of this product pigtail was kink.The wire guide could not get into the zso-7-12.
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Importer site contact and address: cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.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).Device evaluation: 1 x zso-7-12 of lot number c1526765 was returned to cirl for evaluation.It was in a used state and it was returned in its original open packaging.In summary the following observations were made during lab evaluation.A kink was noted at the 2nd porthole on the tapered end of the stent.A 0.035 inch wireguide would not pass the kink.Complaint is confirmed as failure was confirmed during lab evaluation.Document review including ifu review: a review of the manufacturing records for the device of lot # c1526765 did not reveal any discrepancy related to the 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 evidence or no evidence to suggest that there are any manufacturing issues associated with lot number c1526765.Prior to distribution all zso-7-12 devices are subjected to visual and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place in cirl.There is also a 100% visual inspection of the product and packaging at packaging, packaging qc, and post sterile qc.The instructions for use, ifu0045-6 which accompanies this device instructs the user to ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ also, there is a precaution included in the instructions for use, ifu0045-6, ¿care must be exercised when straightening the pigtail curls in order to avoid kinking or breaking the stent.¿ root cause review: a definite root cause cannot be determined, as the circumstances of use cannot be replicated in the laboratory.A possible cause of this complaint is that the kink occurred while being straightened while being passed over wire guide.A precaution included in instructions for use, ifu0045-6 states "care must be exercised when straightening the pigtail curls* in order to avoid kinking or breaking the stent." 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.As the smaller diameter 0.025¿ wire guide occupies less space in the lumen of the pigtail stent it is likely that the extent of the curvature of the pigtail will be greater when a 0.025.As per additional information received the user used a 0.025" wire guide.Summary: complaint is confirmed as failure was confirmed during lab evaluation.As per information provided, the patient did not experience any adverse as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent kinked/ bent'.Before using this product for procedure, the side hole of this product pigtail was kink.The wire guide could not get into the zso-7-12.

• 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: 8163485
• Report Number: 3001845648-2018-00584
• Device Sequence Number: 2879169
• Product Code: FGE
• UDI-Device Identifier: 00827002217089
• UDI-Public: (01)00827002217089(17)210803(10)C1526765
• 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,Followup
• Report Date (Section B): 01/11/2019

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: 08/03/2021
• Device Model Number: G21708
• Device Catalogue Number: ZSO-7-12
• Device Lot Number: C1526765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/13/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 11/28/2018; 11/28/2018
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 01/10/2019; 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1