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

Model Number	G21396
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Exemption number: e2016031.(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
The user straightened the pig tail using the straightener and attempted to advance it over a wire guide(size unknown), but the wire guide would not go through the stent lumen.He then checked the stent and found the kink in the pig tail part.He replaced it with another stent to complete the procedure.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
Device evaluation: 1 x zebd-7-7 of lot # c1606537 was returned to cirl for evaluation open without its original packaging.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 12th july 2019.A kink & perforation from the wireguide was observed on the 4th porthole at the tapered and non-tapered end of the stent.The stent was also kinked at the 2nd porthole at the tapered end and the 1st porthole at the non-tapered end.A 0.035-inch wireguide passed through the stent.A 0.035 inch wireguide would not pass the kinks.Document review including ifu review: prior to distribution zebd-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 zebd-7-7 of lot number c1606537 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 c1606537.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 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 it was being loaded onto the wire guide.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
The user straightened the pig tail using the straightener and attempted to advance it over a wire guide(size unknown), but the wire guide would not go through the stent lumen.He then checked the stent and found the kink in the pig tail part.He replaced it with another stent to complete the procedure.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: 8822176
• Report Number: 3001845648-2019-00359
• Device Sequence Number: 19454088
• Product Code: FGE
• UDI-Device Identifier: 00827002213968
• UDI-Public: (01)00827002213968(17)220418(10)C1606537
• 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
• Report Date (Section B): 07/24/2019

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: 04/18/2022
• Device Model Number: G21396
• Device Catalogue Number: ZEBD-7-7
• Device Lot Number: C1606537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/24/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1