MAUDE Adverse Event Report: FLEXIMA BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number M00539270

Device Problems Positioning Failure (1158); Stretched (1601); Use of Device Problem (1670); Deformation Due to Compressive Stress (2889); Material Deformation (2976); Material Split, Cut or Torn (4008)

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

Event Date 11/28/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a flexima biliary preloaded stent was used to treat biliary stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2023.During the procedure, the stent was unable to deploy.The procedure was completed with another flexima biliary preloaded stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: it was reported that the guidewire was inside the patient during the attempted deployment.However, the flexima biliary stent with delivery system instructions for use (ifu) states, "completely retract the guidewire into the endoscope.If the guidewire is not completely retracted into the delivery system, the stent can not be fully deployed." additionally, it was also reported that the barb flap cover was not used to insert the device through the biopsy cap.Per ifu, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." the physician did not follow the steps cited in the ifu.This event has been deemed an mdr reportable event based on the investigation results which revealed that the stent barb was torn.Please see block h10 for full investigation details.

Manufacturer Narrative

Block e1: the initial reporter's address is (b)(6).Block h6: imdrf device code a0414 captures the reportable investigation results of stent barb torn.Block h10: a flexima biliary preloaded stent was received for analysis.The stent was received still attached to the push catheter.Visual inspection found the guide catheter pulled to the brown marker and was stretched and kinked.The stent barb was torn and the push catheter was damaged.During functional inspection, the stent was deployed manually by pulling the remaining guide catheter.No other problems were noted with the device.The reported event of stent failure to deploy was confirmed as the stent was received still attached to the push catheter.A product labeling review identified that the device was not used in accordance with the instructions for use (ifu) / product label.It was reported that the guidewire was inside the patient during the attempted deployment.However, the flexima biliary stent with delivery system instructions for use (ifu) states, "completely retract the guidewire into the endoscope.If the guidewire is not completely retracted into the delivery system, the stent can not be fully deployed." additionally, it was also reported that the barb flap cover was not used to insert the device through the biopsy cap.Per ifu, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." it is most likely that the barb flap cover not being used to insert the device through the biopsy cap caused the observed event of stent barb torn which resulted in the resistance when trying to deploy the stent during the procedure.Therefore, a review and analysis of all available information indicated the most probable cause is failure to follow instruction.

• Brand Name: FLEXIMA BILIARY
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• MDR Report Key: 18716220
• MDR Text Key: 336522314
• Report Number: 3005099803-2024-00479
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• PMA/PMN Number: K965147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00539270
• Device Catalogue Number: 3927
• Device Lot Number: 0029037233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2022
• 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
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 79 KG