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

Catalog Number ZSS-10-4-RB

Device Problems Failure to Advance (2524); Difficult to Advance (2920)

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

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Per complaint form: not known except for the report that this 10fr stent did not fit through an olympus t1 or t2 scopes which have 3.7mm working channel.I will find out more from the account on 12/22, did any unintended section of the device remain inside the patient¿s body? no.Was the patient hospitalized or was there prolonged hospitalization? no.Did the patient require any additional procedures due to this occurrence? no.Did the product cause or contribute to the need for additional procedures? no.Has the complainant reported any adverse effects on the patient due to this occurrence? no.Has the complainant reported that the product caused or contributed to the adverse effects? n/a.The following information has been requested via email on 09dec2022 / 13dec2022.Sg 13dec2022.Does the complaint relate to: device placement? device removal? observation prior to patient contact? what was the target location for the stent? please describe the storage conditions of the device prior to use especially those pertaining to temperature and light exposure.What is the reorder number, diameter and length of the wire guide that was used with this device in this procedure? was the wire guide lubricated prior to use? was the wire guide inspected for damage prior to use? was the device at the center of the complaint inspected for damage prior to use? were previous procedures ( i.E.Sphincterotomy etc.) carried out prior to placing the complaint device? if yes, please indicate the procedure performed.Did the patient involved exhibit altered anatomy or tortuous anatomy? if not with the device in question, how was the procedure finished? 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? n/a, same procedure, another day.Were any other defects observed on the device prior to return (other than the reported complaint issue? if yes, please detail any other defects observed.Had a sphincterotomy been performed prior to this occurrence? what is the endoscope manufacturer, the model number and working channel size that was used for the procedure? does your medical facility have a service/maintenance schedule associated with its endoscopes? please indicate the location in the body where the stent device was to be placed.( i.E.Biliary duct, pancreatic duct, other.) if other, please specify.Was resistance encountered when advancing the wire guide to the target location? was resistance encountered when advancing the introduction system in place to the target location? 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? if so, please indicate what device(s) were used.Was resistance encountered when advancing the stent through the obstructed area? after placement, was stent position verified? if yes, please describe how.Please estimate the amount of time the stent was in place prior to this occurrence.Did any section of the device detach inside the endoscope or patient? if yes, please specify what section of the device broke off: please indicate whether the device broke in the endoscope or in the patient.N/a, endoscope, patient.Was the broken device retrieved? if yes, please indicate what tools were used during retrieval (e.G.Basket, balloon, snare, forceps etc.): were any modifications made to the complaint device or accessories used with the device in this procedure? (e.G.Guiding catheter shortened, stent cut etc.).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.Did the patient require any additional procedures as a result of this event? 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? n/a, same procedure, another day.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? if yes, please specify what was observed and where on the device it was observed.

Event Description

Supplemental follow-up mdr report is being submitted due to the completion of the investigation on the 04-may-2023.

Manufacturer Narrative

Device evaluation: 1 x zss-10-4-rb of unknown lot number that was involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This file captures the advancement failure of the zss-10-4-rb stent.This file is related to (b)(4) (emdr ref.- 3001845648-2023-00092) which captures the off label use for placement of the zss-10-4-rb stent through pre-placed axios stent.Lab evaluation: the device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.Document review: manufacturing records review could not be completed as the lot number is unknown.Historical data was not reviewed as the lot number is unknown.Prior to distribution all zss-10-4-rb devices are subjected to visual and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place in cirl.It should be noted that the instructions for use states the following ¿if package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.Please notify cook for return authorization¿.There is no evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the user using a faulty endoscope as in the additional information that was sought it was noted that the scope had been repaired a lot and sometimes the lining is not smooth, therefore this factor could contribute to the advancement failure of the stent into the endoscope.Summary: the complaint is confirmed based on customer testimony.According to the information reported, 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.

• Brand Name: SOLUS BILIARY STENT AND INTRODUCER 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: 16102978
• MDR Text Key: 308621968
• Report Number: 3001845648-2023-00008
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZSS-10-4-RB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/30/2022
• Event Location: Hospital
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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