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

Model Number M00523490

Device Problems Break (1069); Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/21/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable investigation result of guide catheter detached/separated.Block h10: the returned flexima plus biliary stent was analyzed, and a visual evaluation noted that the stent was attached to the delivery system.The guide catheter was kinked, stretched and detached.The push catheter suture hole was torn.No other problems with the device were noted.The reported event of stent failure to deploy was confirmed.Based on all the gathered information, the failure that were found could have been caused by operational factors such as the deployment technique of the stent, and excess force was applied during the retraction of the guide catheter, causing friction between the push catheter and guide catheter, which has caused to the detachment of the guide catheter and the analyzed failures, since these are a consequence of the reported deployment failure.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.

Event Description

It was reported to boston scientific that a flexima plus biliary stent was used during an endoscopic balloon dilatation (ebd) procedure in the distal bile duct, performed on (b)(6) 2023.During the procedure and inside the patient, the stent could not be released.Another flexima plus biliary stent was opened and used to successfully complete the procedure.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results; guide catheter detached/separated.Please see block h10 for full investigation details.

• 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: 18003629
• MDR Text Key: 326487263
• Report Number: 3005099803-2023-05463
• 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: 10/25/2023

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: M00523490
• Device Catalogue Number: 2349
• Device Lot Number: 0031014202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2023
• 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