MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 BILIARY SELF EXPANDING METAL STENT; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Model Number	G50621
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: k163018.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
User opened the package and found out the sheath surface detached near handle.No use on patient.User changed another same device to complete the procedure.
Additional Manufacturer Narrative
Pma/510(k)#: k163018.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
User opened the package and found out the sheath surface detached near handle.No use on patient.User changed another same device to complete the procedure.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿flexor breaking (incl.Flexor/handle separation)¿.No adverse effects to the patient have been reported as occurring.
Additional Manufacturer Narrative
Pma/510(k) #: k163018.Device evaluation: the zilbs-635-10-6 device of lot number c1398198 involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 12 september 2019.On evaluation of the device it was observed that the outer sheath was separated from the handle.Document review: prior to distribution zilbs-635-10-6 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.(b)(4) instructs the manufacturing team member (mtm) to ¿check that the outer sheath and handle are fully snapped together and are free from damage and or cracks¿ by means of a visual inspection.Step 1.13 instructs the mtm to ¿check the outer sheath for crumpling, kinks or any other damage¿ and step 1.14 advises the mtm to scrap any defective units; ¿in the case of defects, the unit is to be scrapped¿.A review of the manufacturing records for zilbs-635-10-6 of lot number c1398198 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 c1398198.The instructions for use (b)(4) instructs the user to inspect the device on removal from the packaging: ¿upon removal from the package, inspect the product to ensure no damage has occurred.¿ there is no evidence to suggest that the customer did not follow the instructions for use.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to device handling.It may be noted that a project (b)(4) has been completed and addresses the issue of outer sheath separation from the handle.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the device did not make patient contact and a new device was opened to complete the procedure.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
User opened the package and found out the sheath surface detached near handle.No use on patient.User changed another same device to complete the procedure.

• Brand Name: ZILVER 635 BILIARY SELF EXPANDING METAL STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; national technology park; limerick
• MDR Report Key: 9009435
• Report Number: 3001845648-2019-00471
• Device Sequence Number: 2802361
• Product Code: FGE
• UDI-Device Identifier: 10827002506210
• UDI-Public: (01)10827002506210(17)200913(10)C1398198
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 10/10/2019

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 Model Number: G50621
• Device Catalogue Number: ZILBS-635-10-6
• Device Lot Number: C1398198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/14/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 08/16/2019; 08/16/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 10/10/2019; 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR