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

Catalog Number UNKNOWN

Device Problem Difficult to Advance (2920)

Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2012

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Mouen a.Khashab, 2012, cotton-huibregtse biliary stent set, predictors of early stent occlusion among plastic biliary stents.The majority of conventional stents used were 7and 10 fr cotton¿huibregtse biliary stents (cook medical, winston-salem, nc).After stent placement, follow-up ercps were scheduled at 3-month intervals for exchange and upsizing of stents, if necessary.If patients presented with early stent occlusion prior to their scheduled procedures, ercp was performed to confirm early occlusion of the stent, exclude other causes of cholestasis, and, if indicated, exchange the stent.Early stent occlusion was defined as a worsening cholestatic liver test results of a severity sufficiently significant to warrant ercp with stent exchange prior to the planned stent exchange, or as symptoms of cholangitis.During the study period, 343 patients (mean age 59.3 years, range 20¿95 years, females 47.8 %) underwent 561 ercp procedures with placement of one or more plastic biliary stents (table 1).Stents were placed for benign indications in the majority (69.5 %) of procedures (table 2).The mean number of stents placed per procedure was 1.2 (range 1¿4), and the mean cumulative diameter of stents placed per procedure was 12 fr (range 7¿40 fr).In this study, early stent occlusion occurred in 73 (13 %) procedures, all of which resulted in unscheduled ercps having to be performed.The presenting symptom was cholangitis in 44 patients.In fact, among the patients enrolled in our study, early stent occlusion occurred in 13 % of the procedures.Difficulty in placing biliary stent(s) in desired positions may account for this result.This file will capture: difficult advancement.

Event Description

The investigation was concluded on the 06-jan-2023, this supplement report is being submitted to include the investigation conclusions.

Manufacturer Narrative

Device evaluation: the 7 3x cotton-huibregtse biliary stent set devices of unknown lot number and rpn involved in this complaint were not available for evaluation.With the information provided, a document-based investigation was conducted.This file was created from the attached journal article to capture 'difficult advancement' 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: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Historical data review: historical data was not reviewed as the lot number is unknown.Ifu & label review: there is no evidence to suggest that the customer did not follow the instructions for use or label.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 could be attributed to patient anatomy thus causing the advancement difficulty (ref.Att.Khashab 2012 clinical input).Summary: the complaint is confirmed based on customer testimony.According to the literature article, the 73 patients all exhibited early stent occlusion and the physician stated that ¿difficulty in placing biliary stent(s) in desired positions may account for this result.¿.Clinical input was sought, and the following was determined regarding the advancement difficulty; ¿it was due to patient's condition, it was not related to stent.¿.

• Brand Name: COTTON-HUIBREGTSE 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: 15083808
• MDR Text Key: 304807935
• Report Number: 3001845648-2022-00452
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• PMA/PMN Number: K851962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/10/2012
• Event Location: Hospital
• Date Manufacturer Received: 06/23/2022
• 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
• Patient Age: 53 YR
• Patient Sex: Male