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

Model Number	G21393
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2019
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
Drainage catheter placement was performed to treat distal bile duct stenosis and the user opened packaging of zebd-7-4/lot c1308385.The user straightened the stent with the straightener and attempted to advance the stent over olympus's visiglide 0.025" but the wire did not pass through the stent.The user checked the stent and found a kink on it.Another device was used instead.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¿.No adverse effects to the patient have been reported as occurring.
Event or Problem Description
Drainage catheter placement was performed to treat distal bile duct stenosis and the user opened packaging of zebd-7-4/lot c1308385.The user straightened the stent with the straightener and attempted to advance the stent over olympus's visiglide 0.025" but the wire did not pass through the stent.The user checked the stent and found a kink on it.Another device was used instead.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¿.No adverse effects to the patient have been reported as occurring.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Device evaluation: the device involved in this complaint was available for return to cirl.A document based review will be complete with the available information.Prior to distribution all zebd-7-4 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-7-4 of lot number c1308385 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 c1308385.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.¿ 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 root cause could be attributed to the use of a non-recommended wire guide with the device.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.Complaint is confirmed based on customer testimony.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
Drainage catheter placement was performed to treat distal bile duct stenosis and the user opened packaging of zebd-7-4/lot c1308385.The user straightened the stent with the straightnter and attempted to advance the stent over olympus's visiglide 0.025" but the wire did not pass through the stent.The user checked the stent and found a kink on it.Another device was used instead.There have been no adcvese 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¿.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: 8825902
• Report Number: 3001845648-2019-00365
• Device Sequence Number: 14057859
• Product Code: FGE
• UDI-Device Identifier: 00827002213937
• UDI-Public: (01)00827002213937(17)191221(10)C1308385
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/23/2019

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: 12/21/2019
• Device Model Number: G21393
• Device Catalogue Number: ZEBD-7-4
• Device Lot Number: C1308385
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/21/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 06/27/2019; 06/27/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 08/23/2019; 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1