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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: k163018.Device evaluation: the zilbs-635-10-6 device of lot number c1447544 involved in this complaint was returned for evaluation, with 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 14may2020.The red safety tab was removed from handle.The stent was returned deployed.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 a review of the relevant manufacturing records ((b)(4)) revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this 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 c1447544.There is no evidence to suggest the user did not follow the ifu(ifu0065-1).Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to excessive force being applied to the handle, and the red safety tab being detached during device preparation.Summary complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, 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.
Event or Problem Description
User opened the package, and found out the stent was premature released about 0.3cm.No use on patient.User changed another same device to complete the procedure.This observation was made prior to patient contact.Lab evaluation confirms red safety lock was removed from handle.

• 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; limerick
• MDR Report Key: 10627202
• Report Number: 3001845648-2020-00746
• Device Sequence Number: 3311902
• Product Code: FGE
• UDI-Device Identifier: 10827002506210
• UDI-Public: (01)10827002506210(17)210131(10)C1447544
• 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
• Report Date (Section B): 09/07/2020

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: 01/31/2021
• Device Model Number: G50621
• Device Catalogue Number: ZILBS-635-10-6
• Device Lot Number: C1447544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/19/2020
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 70