MAUDE Adverse Event Report: COOK IRELAND LTD ZIMMON BILIARY STENT SET; FGE CATHETER, BILIARY, DIAGNOSTIC

Catalog Number ZEBD-7-12

Device Problems Dent in Material (2526); Difficult to Advance (2920)

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

Event Date 08/21/2023

Event Type  malfunction  

Event Description

The doctor made an diagnosis that need to place 2 stents.After first stent(zebd-7-12) completion, the second stent was stuck at channel and can not push into the scope.Finally, he replace a new device to complete this case.

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Device evaluation: 01 x zebd-7-12 zimmon biliary stent set of lot number c2018481 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.The device related to this occurrence underwent a laboratory evaluation on (b)(6)2023.The lab evaluation notes, and lab attendees can be verified in the ¿returned product-notes ¿section.The returned device lab examination findings and observations can be referred through attached files.On evaluation it was noted that positioner and stent returned, no pigtail straightener returned.Kink observed on the 3rd, 4th & 5th porthole on the tapered end.Compression damage on the non-tapered end of the stent, end of stent deformed.Kinks observed on the 2nd and 3rd porthole, severe kink on 4th porthole of the non-tapered end.A 0.035" wire guide does not pass the kinks.Manufacturing records review: prior to distribution all devices are subjected to visual and functional checks to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Historical data review: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use /or label review: the instructions for use, (ifu0045) which accompanies this device instructs the user to ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ there is no evidence to suggest the customer did not follow the instructions for use.Image review: as per image provided, single pigtail plastic stent can be seen within the tyvek pouch.Due to the position of the map 80 label covering the majority of the stent it is not possible to see the damage on the stent.Root cause analysis: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.Also, due to limited information received on this file as several attempts were made and no information was provided by the customer to assist in with identifying the complaint failure reported only a possible root cause can be assumed.A possible root cause could be attributed to the user applying excessive force during straightening of the pigtail curl, therefore causing the kinks and the compression damage noted on the stent which in turn lead to difficulty advancement into the endoscope.Confirmation of complaint: the complaint confirmed based on visual and/or functional inspection.Corrective action/correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: failure identified: multiple kinks on tapered end of stent.Compression damage and severe kinks on the non-tapered end of the stent, end of stent deformed, confirmed quantity of 01 device reported used.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 user applying excessive force during straightening of the pigtail curl, therefore causing the kinks and the compression damage noted on the stent which in turn lead to difficulty advancing and placing the stent.The complaint confirmed based on visual and/or functional inspection.The patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 07-mar-2024.

• Brand Name: ZIMMON BILIARY STENT SET
• Type of Device: FGE CATHETER, BILIARY, DIAGNOSTIC
• 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: 17815807
• MDR Text Key: 324224693
• Report Number: 3001845648-2023-00732
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 10827002215266
• UDI-Public: (01)10827002215266(17)260120(10)C2018481
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K851962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZEBD-7-12
• Device Lot Number: C2018481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/21/2023
• Event Location: Hospital
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2023
• 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
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 50 KG