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

Model Number	G22122
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: 1 x zebd-5-10 of lot # c1600101 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 26th july 2019.A kink and perforation were observed on the 2nd porthole at the inked end of the stent and the 3rd porthole at the non-inked end of the stent.A 0.035-inch wireguide would not pass the kinks.Information was provided to say that the kink occurred prior to contact with the wireguide, the user attempted to see if they could advance a 0.025-inch wireguide through the kinked stent but could not and therefore the stent was not used.Documents review including ifu review: prior to distribution all zebd-5-10 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.A review of the manufacturing records for zebd-5-10 of lot number c1600101 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 c1600101.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, the user is instructed by the instructions for use, ifu0045-6: ¿care must be exercised when straightening the pigtail curls* in order to avoid kinking or breaking the stent.¿ there is no evidence to suggest that the user did not follow the instructions for use.Root cause review: a definitive root cause cannot be determined, as the circumstances of use cannot be replicated in the laboratory and due to limited information.A possible cause of this complaint may be that the kink occurred while being straightened, as per the instructions for use: ¿¿care must be exercised when straightening the pigtail curls* in order to avoid kinking or breaking the stent.¿ summary: complaint is confirmed as the failure was verified in the laboratory.According to the information reported, 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.
Event or Problem Description
Prior to patient contact, the user attempted to straighten the pig tail stent (zebd-5-10/ c1600101) with the straightener but the stent kinked during the attempt.Another zebd-5-10 was used instead and the procedure was completed.There have been no adverse effects to the patient reported.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 SET
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8873510
• Report Number: 3001845648-2019-00399
• Device Sequence Number: 19489213
• Product Code: FGE
• UDI-Device Identifier: 00827002221222
• UDI-Public: (01)00827002221222(17)220328(10)C1600101
• 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
• Report Date (Section B): 07/11/2019

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: 03/28/2022
• Device Model Number: G22122
• Device Catalogue Number: ZEBD-5-10
• Device Lot Number: C1600101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/10/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1