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

Catalog Number	ZSO-7-10
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/11/2017
Type of Reportable Event	Serious Injury
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 1 x zso-7-10 of lot c1313077 was returned to cirl for an evaluation.During the lab evaluation it was determined that there were no anomalies on the device that could have contributed to the migration event.The pigtail anti-migration features were found to be correct/ as expected.There was evidence of damage noted on the duodenal end of the stent which is consistent with the removal of the stent.It was noted during the lab evaluation that the anti-migration feature (in this case the pigtails) should be placed just above the stricture and that the most probable root cause of this customer complaint could be attributed to incorrect size selection (both too short or too long for the stricture) could cause migration, or incorrect placement of the stent across the stricture which could also attribute to stent migration.It is also possible that the user used an incorrect method to place the stent or to remove the introducer components.However as the operational conditions of use could not be replicated in the laboratory setting, it is not possible to conclusively determine the root cause of the customer complaint.The customer complaint was confirmed based on customer testimony.As per instructions for use (ifu) : ¿this device is used to drain obstructed biliary ducts¿.As per a precaution included in the instructions for use for this device: ¿the tapered tip end of the stent* or side holes* must be positioned in the common bile duct while the other end remains in the duodenum.¿ step 6 of the ifu instructs the user "after confirming stent position, gently remove wireguide, then guiding catheter* from endoscope while maintaining position of stent with pushing catheter".Step 7 then instructs to "gently remove pushing catheter from accessory channel".It should be noted that stent migration is stated as a potential complication associated with the placement of zso devices in the ifu.Prior to distribution all zso devices are subjected to visual inspection and functional checks to ensure device integrity.There is also a visual inspection of the product and packaging at packaging, packaging qc, and post sterile qc.A review of the manufacturing records for the biliary stent device of lot c1313077 did not reveal any discrepancy related to the complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1313077; upon review of complaints this failure mode has not occurred previously with this lot # c1313077.Prior to distribution, all zso--7-10 devices are subjected to 100% inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
They were able to confirm the stent migration immediately after placement of the stent.So they removed migration stent.

• 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: 6557000
• Report Number: 3001845648-2017-00167
• Device Sequence Number: 628174
• Product Code: FGE
• UDI-Device Identifier: 00827002217072
• UDI-Public: (01)00827002217072(17)200110(10)C1313077
• 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): 04/12/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ZSO-7-10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/10/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2017
• Initial Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention