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

Model Number M00539270

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 06/07/2023

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 biliary stent was analyzed, and a visual evaluation noted that the guide catheter was bent/kinked, stretched and was detached from the delivery system.The suture was untied, and the push catheter suture hole was torn.No other problems with the device were noted.The reported event was confirmed.Based on all the gathered information and product analysis, the failures found could have been caused by operational factors such as the deployment technique that was used at the time the stent was released, since an excess of force was applied to the device, this caused the detachment of the guide catheter from the delivery system, causing it to stretch and kink.Due to the detachment, the device loses its functionality.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 biliary stent was used during a stent placement procedure in the bile duct, performed on (b)(6) 2023.During the procedure and inside the patient, the stent could not be deployed.Another flexima biliary stent was opened and used to complete the procedure.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.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 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: 17599840
• MDR Text Key: 321713689
• Report Number: 3005099803-2023-04515
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729162582
• UDI-Public: 08714729162582
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• 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: 0028118657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2021
• 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: 38 YR
• Patient Sex: Male
• Patient Weight: 65 KG