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

Catalog Number	ZILBS-635-10-6
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
When the wire guide (olympus/visiglide2 0.025inch angled) was inserted into the tip of zilbs-635-10-6, the user felt something was wrong (it was not inserted smoothly), so he stopped using it.The procedure was completed by using another size (10-8)(lot#: unknown). since this facility uses this product on a regular basis, we do not see any problem with its usage.1 general questions for all complaints.1-1 (if any damages were confirmed prior to use)was the package damaged? no.1-2 (if any damages were confirmed prior to use)how was the device stored? 1-3 was a sphincterotomy or balloon dilation performed prior to use of the stent device? no.1-4 was post-dilation performed after the placement of the stent? no.1-5 what brand of endoscope was used with the device? olympus/tjf-260v 1-6 what was the target location for the complaint device? common bile duct 1-7 was the device flushed through both flushing ports before the procedure, as per ifu? yes 1-8 details of the wire guide used (name, diameter, hyrdophyllic)? 1-9 was resistance encountered when advancing the wire guide or delivery system to the target location? no.1-10 how did the physician deal with this resistance? 1-11 was the patient's anatomy tortuous? no.1-12 did the tip of the delivery system cross the target location? no.1-13 did the user pull the handle toward the hub during deployment and delivery system was not pushed during deployment? yes.1-14 was the stent being placed through the side wall of a previously placed stent? no.1-15 was the elevator in the down position during deployment? yes.1-16 are images of the device of procedure available? no.7 difficulty advancing over the wire guide: 7-1 details of the wire guide used (diameter, hydrophyllic, make)? 7-2 was the stent device flushed through the flushing port(s) before the procedure, as per ifu? yes.7-3 was the patient¿s lesion heavily calcified / anatomy tortuous? no.
Additional Manufacturer Narrative
Pma/510(k) #k163018.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Pma/510(k) # k163018.Cancellation report is being submitted due to additional information received on 30-jan-2024.Fda mdr reporting not required.No reporting malfunction precedence exists for this complaint event for this product family.No risk/ low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.
Event or Problem Description
Cancellation report is being submitted due to additional information received on 30-jan-2024.Fda mdr reporting not required.No reporting malfunction precedence exists for this complaint event for this product family.No risk/ low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.

• 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
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 18009328
• Report Number: 3001845648-2023-00805
• Device Sequence Number: 7313828
• Product Code: FGE
• UDI-Device Identifier: 10827002506210
• UDI-Public: (01)10827002506210(17)260116(10)C2016373
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2024

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: 01/16/2026
• Device Catalogue Number: ZILBS-635-10-6
• Device Lot Number: C2016373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/28/2023
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown