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

Model Number M00523450

Device Problems Positioning Failure (1158); Stretched (1601); Material Deformation (2976); Material Split, Cut or Torn (4008)

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

Event Date 12/25/2023

Event Type  malfunction  

Manufacturer Narrative

Block e1: initial reporter city: (b)(6).Block h6: imdrf device code a0414 captures the reportable investigation finding of stent barb torn.Block h10: a flexima plus biliary stent and delivery system were returned for analysis.Visual examination of the returned device found the stent was still attached to the delivery system and the guide catheter was stretched.Additionally, there were remnants of use in the device.Microscopic inspection was performed, and the stent barb and the push catheter suture hole were torn.A media inspection of the photo provided by the customer showed the stent inside the patient and bent.The reported events of guide catheter stretched and failure to deploy were confirmed.It is possible that during an attempted deployment the remnants in the device got stuck and would not allow the suture to deploy the stent.Additionally, the damage to the stent, stent barb, guide catheter and push catheter suture hole could have been generated due to the force applied to the device when attempting to deploy with the stent stuck.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation that a flexima plus biliary stent was to be implanted in the common bile duct for the treatment of stones during an endoscopic biliary stent placement procedure performed on (b)(6) 2023.During the procedure, the stent could not be deployed, and the guide catheter was stretched.The procedure was completed using another flexima plus biliary stent.There were no patient complications reported as a result of this event.Note: 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.

• 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: 18789997
• MDR Text Key: 336615428
• Report Number: 3005099803-2024-00643
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00523450
• Device Catalogue Number: 2345
• Device Lot Number: 0032824890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2023
• 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