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

Model Number	G21673
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
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.Investigation is pending.A follow up mdr will be submitted with the investigation conclusions.
Event or Problem Description
The biliary stent bent during assembly in the endoscope.
Additional Manufacturer Narrative
(b)(4).Exemption number: e2016031.Importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Additional information received on 13-nov-2017: "was it during assembly in the endoscope? yes it was, when dr saw the stent he decided to stop".Lab evaluation: 1 x clbs-10-15 device was returned to cirl for evaluation.A lab evaluation was held on 12 oct 2017 upon evaluation of the returned device crumpling was noted at the ductal flap.No other defects observed.Root cause: a definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting.However it is possible that the damage may have been caused by excessive force during advancement into the endoscope.Ifu review: it may be noted that according to the instructions for use, ifu0045-6, the user is instructed to visually inspect the device ¿if any abnormality is detected that would prohibit proper working condition, do not use¿.Fqc/ prd review: prior to distribution all biliary devices are subject to visual inspection to ensure device integrity.These inspections are outlined in internal procedures in place at cook (b)(4).Document review: a review of the manufacturing records for the biliary stent device of lot c1347451 did not reveal any discrepancy related to the complaint issue.Summary: this complaint is confirmed as the stent was found to be damaged.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
This follow up mdr is being submitted due to additional information received.Additional information received on 13-nov-2017: was it during assembly in the endoscope? yes it was, when dr saw the stent he decided to stop.
Additional Manufacturer Narrative
(b)(4).Exemption number: e2016031.Importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Lab evaluation: 1 x clbs-10-15 device was returned to cirl for evaluation.A lab evaluation was held on 12 oct 2017.Upon evaluation of the returned device crumpling was noted at the ductal flap.No other defects observed.Root cause: as there has been no response as of yet to the additional information request, a potential root cause cannot be determined as we do not know when the damage to the stent was noticed.If the initial description of event is to go by then the damage may have been caused by excessive force during advancement into the endoscope.If the stent was damaged whilst inside the packaging, this may be due to storage and/ or transportation conditions.Ifu review: it may be noted that according to the instructions for use, the user is instructed to visually inspect the device ¿if any abnormality is detected that would prohibit proper working condition, do not use¿.Fqc/ prd review: prior to distribution all biliary devices are subject to visual inspection to ensure device integrity.These inspections are outlined in internal procedures in place at cook ireland.Document review: a review of the manufacturing records for the biliary stent device of lot c1347451 did not reveal any discrepancy related to the complaint issue.Summary: this complaint is confirmed as the stent was found to be damaged.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
The biliary stent bent during assembly in the endoscope.

• Brand Name: COTTON-LEUNG BILIARY STENT SET
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 6917175
• Report Number: 3001845648-2017-00428
• Device Sequence Number: 13783975
• Product Code: FGE
• UDI-Device Identifier: 00827002216730
• UDI-Public: (01)00827002216730(17)200419(10)C1347451
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: G21673
• Device Catalogue Number: CLBS-10-15
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/05/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 09/07/2017; 11/13/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 11/03/2017; 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1