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

Model Number M00539240

Device Problems Break (1069); Use of Device Problem (1670); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/02/2024

Event Type  malfunction  

Manufacturer Narrative

Block e1: the initial reporter facility name is (b)(6).Block h6: imdrf device code a0401 captures a reportable event of a guide catheter break.

Event Description

It was reported to boston scientific corporation that a flexima biliary stent was to be implanted in the biliary tract to treat stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During preparation, the guide catheter was noted to be broken when the device was unpacked.The procedure was completed with another flexima biliary stent.There were no patient complications reported as a result of this event, and the patient's condition after the procedure was reported to be stable.

Manufacturer Narrative

Block e1: the initial reporter facility name is (b)(6).Block h6: imdrf device code a0401 captures a reportable event of a guide catheter break.Block h10: the flexima biliary preloaded stent and delivery system were returned for analysis.Visual inspection found that the suture hole of the push catheter was torn, and the push catheter was bent.Media analysis found that the guide catheter was bent.No other damages were noted with the stent or delivery system.Product analysis did not confirm the reported event of a guide catheter break, but the reported events of guide catheter kink and device user error were confirmed.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, and the broken inner guide catheter remained within the push catheter.However, the flexima biliary stent with delivery system instructions for use (ifu) states, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion.Thus, the user did not follow the manufacturer's instructions.Additionally, the investigation concluded that the guide catheter kinking and the additional investigation finding of push catheter bending and push catheter suture hole being torn were most likely due to procedural factors such as lesion characteristics, the handling of the device, and the technique used by the physician (force applied) that could have resulted in the damages noted in the device.Therefore, a review and analysis of all 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 biliary stent was to be implanted in the biliary tract to treat stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During preparation, the guide catheter was noted to be broken when the device was unpacked.The procedure was completed with another flexima biliary stent.There were no patient complications reported as a result of this event, and the patient's condition after the procedure was reported to be stable.

• 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: 18587391
• MDR Text Key: 334731972
• Report Number: 3005099803-2024-00084
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729162551
• UDI-Public: 08714729162551
• 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,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00539240
• Device Catalogue Number: 3924
• Device Lot Number: 0031997786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2023
• 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
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 60 KG