MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA PLUS BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number M00523500

Device Problems Break (1069); Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/06/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a flexima plus biliary stent was to be implanted in the bile duct during an endoscopic biliary stent placement procedure performed on (b)(6) 2023.During the procedure, the suture was not able to release.The procedure was completed with another flexima plus biliary stent.There were no patient complications reported as a result of this event.Note: it was reported that the barb flap cover was not used to insert the device through the biopsy cap.Per the instructions for use (ifu), "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." the user did not follow the ifu.The investigation results revealed that the guide catheter was detached; therefore, this is now an mdr reportable event (see block h10 for investigation details).

Manufacturer Narrative

Block h6: imdrf a0401 captures the reportable investigation finding of guide catheter detachment.Block h10: the flexima plus biliary stent and delivery system were received for analysis.Visual analysis found that the stent was still attached to the push catheter.Visual and microscopic inspection found that the guide catheter was stretched, kinked, and detached.Additionally, the suture was returned in good condition.Destructive analysis was performed by pulling the guide catheter from the distal section, and it was found to be detached.Product analysis did not confirm the reported suture deployment issue.The investigation concluded that the reported event and the additional investigation findings may be due to operational factors such as the deployment technique of the stent, excessive force application during the guide catheter retraction, and friction between the push catheter and guide catheter that may have caused the stretching and detachment of the guide catheter that consequently resulted in the failed deployment of the stent.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu)/product label.It was reported that the barb flap cover was not used to insert the device through the biopsy cap.Per the instructions for use (ifu), "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.

• Brand Name: FLEXIMA PLUS BILIARY
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18132681
• MDR Text Key: 328068045
• Report Number: 3005099803-2023-06145
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00523500
• Device Catalogue Number: 2350
• Device Lot Number: 0031665303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• 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