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

Catalog Number ZEBD-7-10

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

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

Event Date 06/15/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The user straightened the pigtail using the straightener and attempted to advance the stent over a wire guide (olympus visiglide2 angled : size unknown) but the wire guide would not pass through the stent lumen.(pr366783) he replaced it with another zebd-7-10 (lot: c1933542), but the same problem occurred.(pr366784) he replaced it with another zebd-7-10 (lot unknown) to complete the procedure.The patient did not experience any adverse effects due to this occurrence.For all complaints: for all complaints, ask: does the complaint relate to:device placement/device removal/observation prior to patient contact already stated in description of event.What was the target location for the stent? already stated in description of event.Please describe the storage conditions of the device prior to use especially those pertaining to temperature and light exposure.Stored in a shelf what is the reorder number, outer diameter and length of the wire guide that was used with this device in this procedure?* already stated in description of event.Was the wire guide lubricated prior to use? yes was the device at the centre of the complaint inspected for damage prior to use? yes was the wire guide inspected for damage prior to use? yes were previous procedures i.E.Sphincterotomy etc.Carried out prior to placing the complaint device? ni if yes please indicate the procedure performed.Did the patient involved exhibit altered anatomy or tortuous anatomy? ni if not with the device in question, how was the procedure finished? already stated in description of event.Did the patient require any additional procedures as a result of this event? ni what intervention (if any) was required? was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? were any other defects observed on the device prior to return (other than the reported complaint issue)? no was a straightener used to straighten the stent? yes (if any damages were confirmed prior to use)was the package damaged? no for complaints occurring during use (once in contact with endoscope) also ask: what is the endoscope manufacturer, the model number and working channel size that was used for the procedure? already stated in description of event.Does your medical facility have a service/maintenance schedule associated with its endoscopes? yes was resistance encountered when advancing the wire guide to the target location? ni was resistance encountered when advancing the introduction system in place to the target location? n/a how did the physician deal with this resistance? how did the physician determine the length of the stent to be used for the procedure? where was the stricture located in the duct? was the stricture dilated prior to placing the device? no was resistance encountered when advancing the stent through the obstructed area? n/a after placement, was stent position verified? n/a if yes, please describe how.Please estimate/indicate the amount of time the stent was in place dwelling prior to this occurrence.N/a did any section of the device detach inside the endoscope or patient? no if yes, please specify what section of the device broke off: please indicate whether the device broke in the endoscope or in the patient? was the broken device retrieved? if yes, please indicate what tools were used during retrieval.Were any modifications made to the complaint device or accessories used with the device in this procedure? ¿ for example guiding catheter shortened.No if yes, please indicate what modifications were made: please indicate why the modifications were necessary.Please indicate any other endoscopic accessories (if any) that came into contact with the stent or introduction system during the procedure.N/a did the patient require any additional procedures as a result of this event? ni what intervention (if any) was required? was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? were any other defects observed on the device prior to return (other than the reported complaint issue)? no if yes, please specify what was observed and where on the device it was observed.

Event Description

Lab evaluation on 20th july 2022: visual inspection: stent and catheter returned.Slight kinks observed on the 2nd and 5th portholes on the tapered end pigtail curl functional inspection: 0.035 inch wire guide does not pass through freely.

Manufacturer Narrative

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

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation on 02-nov-2022 and an update to the investigation conclusions.

Manufacturer Narrative

Device evaluation: 1 x zebd-7-10 device of lot c1932092 was returned opened in its original packaging to cirl.With the information provided, a physical and a document-based investigation was conducted.Lab evaluation: lab evaluation 20th july 2022.Visual inspection: stent and catheter returned.Slight kinks observed on the 2nd and 5th portholes on the tapered end pigtail curl functional inspection: 0.035-inch wire guide does not pass through freely.Document review: prior to distribution all zebd-7-10 devices are subject 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.The japanese packaging insert supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.A review of the manufacturing records for zebd-7-10 of lot number c1932092 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 lot number c1932092.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot c1932092.It should be noted that the instructions for use states the following: ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.Notify cook for return authorization¿.¿care must be exercised when straightening the pigtail curls in order to avoid kinking or breaking the stent¿.There is no evidence to suggest the user did not follow the ifu.Image review: n/a 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, whereby the kink occurred while being straightened as it was being loaded onto the wire guide.Summary: failure identified: stent kinked.Confirmed quantity of 1 device, used.Investigation findings conclude a non-definitive root cause of excessive force.The kink may have occurred while being straightened as it was being loaded onto the wire guide.According to the initial report, the patient did not experience any adverse effects.The complaint is confirmed as the failure was verified in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 15008601
• MDR Text Key: 304693168
• Report Number: 3001845648-2022-00421
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 10827002257945
• UDI-Public: (01)10827002257945(17)250411(10)C1932092
• Combination Product (y/n): N
• 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,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZEBD-7-10
• Device Lot Number: C1932092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/15/2022
• Event Location: Hospital
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2022
• 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