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

Model Number	G21656
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	08/29/2019
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
Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent kinked/bent' and 'difficult advancement'.Upon preparation, the user was using the device is an oasis device and noted that the stent began to scrunch on the introducer.The device was put aside.A new device of the same lot number was pulled for use and was used to successfully complete the procedure.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent kinked/bent' and 'difficult advancement'.Upon preparation, the user was using the device is an oasis device and noted that the stent began to scrunch on the introducer.The device was put aside.A new device of the same lot number was pulled for use and was used to successfully complete the procedure.
Additional Manufacturer Narrative
1 x chbso-10-7 device of lot # c1593332 was returned to cirl for evaluation opened with its original packaging.The device was evaluated in the lab on the 11th october 2019.Forceps like marks were noted on the non-tapered end of the stent after the skive hole.Prior to distribution chbso-10-7 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for chbso-10-7 of lot number c1593332 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 c1593332.As per instructions for use (ifu0045-6) ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ the user is also instructed as follows: ¿care must be exercised when straightening pigtail curl in order to avoid kinking or breaking catheter.¿ there is no evidence to suggest that the user did not follow the instructions for use.A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.The oasis introducer used was deemed appropriate for use.A possible root cause may be attributed to handling of the device or difficulty advancing the stent with the introducer over the wireguide due to patient anatomy.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 emerging trends.
Event or Problem Description
Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent kinked/bent' and 'difficult advancement'.Upon preparation, the user was using the device is an oasis device and noted that the stent began to scrunch on the introducer.The device was put aside.A new device of the same lot number was pulled for use and was used to successfully complete the procedure.

• Brand Name: COTTON-HUIBREGTSE BILIARY STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9125954
• Report Number: 3001845648-2019-00495
• Device Sequence Number: 2820164
• Product Code: FGE
• UDI-Device Identifier: 00827002216563
• UDI-Public: (01)00827002216563(17)220308(10)C1593332
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2019

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: 03/08/2022
• Device Model Number: G21656
• Device Catalogue Number: CHBSO-10-7
• Device Lot Number: C1593332
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/29/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 08/30/2019; 08/30/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 10/24/2019; 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1