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

Model Number	G25672
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Address of user facility documented in additional data section of entity details.
Event or Problem Description
"products wouldn't work.Any of the solus double pigtail stents with introducers would not go through the wire locks."as per complaint form": when trying to use these stents , the stent would not feed through the wirelock- it was impossible to move it through as the stent isnt tappered.When we removed the wirelock it was also too difficult to push the stent into the duct.Finished by using a 7french double pigtail stent instead which the doctor didnt want to use unfortunately.
Event or Problem Description
"products wouldn't work.Any of the solus double pigtail stents with introducers would not go through the wire locks."as per complaint form": when trying to use these stents, the stent would not feed throught the wirelock- it was impossible to move it through as the stent isnt tapered.When we removed the wirelock it was also too difficult to push the stent into the duct.Finished by using a 7french double pigtail stent instead which the doctor didn't want to use unfortunately.This report being submitted is complete follow up mdr report due to the investigation being signed of on 31-aug-2020.
Additional Manufacturer Narrative
Device evaluation: 3 x zss-10-5-rb of lot number c1662694 were returned to cirl unopened in its original packaging.Compliant device was not returned.This compliant is related to (b)(4) which deals with the same complaint of device with an rpn of zss-10-7-rb.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on (b)(6) 2020.The returned device lab findings and observations can be referred through the attached files.Unopened devices returned; complaint devices not returned.Engineering advice during lab evaluation that wire locks were not intended to be used with device.Information requested as to the complaint device once as per dev # dv0001519, doc.# dv0001556 image review: n/a.Documents review including ifu review: prior to distribution all zss-10-5-rb 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.(d00059776 [qsi0975] rev031, [prd0111] rev022 and d00055252 [fqc0062] rev018).A review of the manufacturing records for zss-10-5-rb of lot number c1662694 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 c1662694.The instructions for use, ifu0100-1 which accompanies this device instructs the user to ¿do not use this device for any other purpose than stated intended use¿ and ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ root cause review: a definitive root cause can be attributed to user error due to the use of a wire lock where it is not mentioned as per the ifu.Summary: complaint is confirmed based on the customer¿s testimony as the clinical setting that could impact on the functionality of the device cannot be replicated 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.

• Brand Name: SOLUS BILIARY STENT AND INTRODUCER SET
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9737896
• Report Number: 3001845648-2020-00113
• Device Sequence Number: 1815689
• Product Code: FGE
• UDI-Device Identifier: 10827002256726
• UDI-Public: (01)10827002256726(17)221024(10)C1662694
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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: 10/24/2022
• Device Model Number: G25672
• Device Catalogue Number: ZSS-10-5-RB
• Device Lot Number: C1662694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/23/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1