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

Model Number	G25794
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
1st device [2nd pr created to capture this]: pigtail of one zebd-7-7/ lot# c1609172 was straightened with a straightener, but a wire guide (olympus/ vigiglide 0.025inch) could not be advanced through the pigtail due to kinks.The device was replaced with another zebd-7-7/ lot# unknown (= the 2nd device below).2nd device [3rd pr created to capture this]: the user attempted to use one zebd-7-7/ lot# unknown though, the pigtail became kinked.The device was replaced with another zebd-7-10/ lot# unknown (= the 3rd device below).3rd device [this pr]: pigtail of one zebd-7-10/ lot# c1632925 was straightened with a straightener, but the wire guide could not be advanced through the pigtail due to kinks.Since the pigtail of the 2nd device was less kinked, the user decided to use the 2nd device and placed it in the bile duct to complete the procedure.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
1st device [2nd pr created to capture this]: pigtail of one zebd-7-7/ lot# c1609172 was straightened with a straightener, but a wire guide (olympus/ vigiglide 0.025inch) could not be advanced through the pigtail due to kinks.The device was replaced with another zebd-7-7/ lot# unknown (= the 2nd device below).2nd device [3rd pr created to capture this]: the user attempted to use one zebd-7-7/ lot# unknown though, the pigtail became kinked.The device was replaced with another zebd-7-10/ lot# unknown (= the 3rd device below).3rd device [this pr]: pigtail of one zebd-7-10/ lot# c1632925 was straightened with a straightener, but the wire guide could not be advanced through the pigtail due to kinks.Since the pigtail of the 2nd device was less kinked, the user decided to use the 2nd device and placed it in the bile duct to complete the procedure.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
Device evaluation: 1 x zebd-7-10 of lot #c1632925 was returned to cirl for evaluation open in its original packaging.(b)(4) and (b)(4) are linked this investigation.Both additional investigations involve an additional kinked stent in the procedure of rpn zebd-7-7.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 22th november 2019.A kink was observed at the 5th portholes on the tapered end of the pigtail.A 0.035-inch wire guide does not pass the kink.Image review: n/a.Document review including ifu review: prior to distribution zebd-7-10 devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for zebd-7-10 of lot number c1632925 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 c1632925.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 could not be determined as the circumstances of use cannot be replicated in the laboratory.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¿ wire guide is used.As per additional information received a 0.025" wire guide was used.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, 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
1st device [2nd pr created to capture this]: pigtail of one zebd-7-7/ lot# c1609172 was straightened with a straightener, but a wire guide (olympus/ vigiglide 0.025inch) could not be advanced through the pigtail due to kinks.The device was replaced with another zebd-7-7/ lot# unknown (= the 2nd device below).2nd device [3rd pr created to capture this]: the user attempted to use one zebd-7-7/ lot# unknown though, the pigtail became kinked.The device was replaced with another zebd-7-10/ lot# unknown (= the 3rd device below).3rd device [this pr]: pigtail of one zebd-7-10/ lot# c1632925 was straightened with a straightener, but the wire guide could not be advanced through the pigtail due to kinks.Since the pigtail of the 2nd device was less kinked, the user decided to use the 2nd device and placed it in the bile duct to complete the procedure.There have been no adverse effects to the patient reported.

• 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: 9368351
• Report Number: 3001845648-2019-00626
• Device Sequence Number: 2197265
• Product Code: FGE
• UDI-Device Identifier: 00827002257948
• UDI-Public: (01)00827002257948(17)220717(10)C1632925
• 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): 02/13/2020

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: 07/17/2022
• Device Model Number: G25794
• Device Catalogue Number: ZEBD-7-10
• Device Lot Number: C1632925
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/28/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 10/30/2019; 10/30/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/19/2019; 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1