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

Model Number G50624

Device Problems Premature Activation (1484); Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #k163018.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

The stent was partially open when opening the package, another stent was placed to this patient.

Manufacturer Narrative

Pma 510k #k163018.Device evaluation the zilbs-635-10-8 device of lot number c1943408 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.The device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Manufacturing records.Prior to distribution all zilbs devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.An nc code (gen-154) was noted on the work order but this unit was subsequently scrapped and could not have contributed to this issue.Review historical data: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use/label: there is no evidence to suggest that the customer did not follow the instructions for use.It should be noted that the instructions for use (ifu0065) states the following: ¿inspect the product to ensure no damage has occurred¿.Image review: an image was not returned for evaluation.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause of impact during transportation could be identified from the available information.The stent was found to be partially deployed when the user was unpacking the device.The user was asked if the red safety tab was present or had that also been dislodged but they could not recall.(ref att (b)(4).Add question regarding red safety tab).It is possible that impact received during transportation could have caused the red safety tab to be knocked out resulting in the stent becoming partially deployed.Another possible root cause could be attributed to incorrect handling of the device when the device was being removed from the packaging.The red safety tab could have accidentally been knocked off which could have led to the stent partially deploying.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Summary: according to the initial reporter, the stent was partially open when opening the package, another stent was placed to this patient.Confirmed quantity of 1 device, confirmed prior to use.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.This occurred prior to patient contact and another device was used to carry out the procedure.Investigation findings conclude definitive root cause could not be determined.Possible root causes could be attributed to impact during transportation or incorrect handling of the device when removing from the packaging, that possibly could have dislodged the red safety tab and resulted in the stent becoming partially deployed complaint is confirmed based on customer and/or rep testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplement report being submitted due to the completion of the investigation on 12-oct-2023.

• Brand Name: ZILVER 635 BILIARY SELF EXPANDING METAL STENT
• Type of Device: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3; limerick
• MDR Report Key: 17216669
• MDR Text Key: 318015432
• Report Number: 3001845648-2023-00516
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 10827002506241
• UDI-Public: (01)10827002506241(17)250518(10)C1943408
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

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
• Device Operator: Health Professional
• Device Model Number: G50624
• Device Catalogue Number: ZILBS-635-10-8
• Device Lot Number: C1943408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/31/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 06/01/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1