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

Model Number M00545560

Device Problems Break (1069); Positioning Problem (3009)

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

Event Date 01/25/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to boston scientific corporation that a flexima biliary stent set was implanted in the bile duct during an endoscopic biliary stent placement procedure performed on (b)(6) 2024.During the procedure, the proximal handle was pulled for release, there was no resistance felt; however, it was no longer able to pull the inner catheter in the middle of the procedure.Subsequently, when the endoscope was removed, it was noticed that the inner catheter was broken and was removed along with the push catheter.The stent remained implanted and the procedure was completed.There were no patient complications reported as a result of this event.

• Brand Name: RX 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: 18705989
• MDR Text Key: 336289027
• Report Number: 3005099803-2024-00485
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729337867
• UDI-Public: 08714729337867
• 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,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00545560
• Device Catalogue Number: 4556
• Device Lot Number: 0032531646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2023
• 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