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

Model Number	G25672
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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
The user is unsure if the guiding catheter was lubricated.When placing the biliary stent, the guiding catheter was pulled and it stretched/broke.Device was removed by hand.The procedure was completed as intended with no adverse events.
Event or Problem Description
The user is unsure if the guiding catheter was lubricated.When placing the biliary stent, the guiding catheter was pulled and it stretched/broke.Device was removed by hand.The procedure was completed as intended with no adverse events.This report being submitted is a complete follow up mdr report due to the investigation being completed.
Additional Manufacturer Narrative
Device evaluation: 1 x zss-10-5-rb of lot number c1658150 was returned to cirl open in its original packaging.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 28st january 2020.The guiding catheter was returned in two pieces, the proximal end was stretched/ deformed.The flare was pulled out.There was stretching evident at approx.30-31 cm and marks were present at approx.18cm possibly from removal.On the pushing catheter there was a kink at 84 cm from the white hub and a severe kink was present on the on the pushing catheter distal shrink tube.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.A review of the manufacturing records for zss-10-5-rb of lot number c1658150 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 c1658150.The instructions for use, ifu0100-1 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.¿.There is no evidence to suggest that the user did not follow the instructions for use.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 could be due to the use of an incorrect wire guide, the user states that they were unsure which wire guide they used.An incorrect wire guide may not have supplied enough support to the device which may have resulted in the kink seen on the pushing catheter causing the guiding catheter to become stretched and damaged as a result.It was noted that the user also stated that they were unsure if they lubricated the guiding catheter as per ifu which may have also contributed to the issue.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.

• 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: 9685888
• Report Number: 3001845648-2020-00084
• Device Sequence Number: 2396271
• Product Code: FGE
• UDI-Device Identifier: 10827002256726
• UDI-Public: (01)10827002256726(17)221010(10)C1658150
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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): 07/09/2020

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: 10/10/2022
• Device Model Number: G25672
• Device Catalogue Number: ZSS-10-5-RB
• Device Lot Number: C1658150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1