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

Model Number	M00545560
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.Block h10: a flexima rx biliary stent set was received for analysis.Visual inspection found the guide catheter detached and kinked.No other problems were noted with the device.Product analysis confirmed the reported event of catheter-guide break.However, the reported event of stent difficult to position was not confirmed because this occurred during the procedure and is not possible to replicate in the laboratory of analysis.It is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied) resulted in the reported event of catheter-guide break and the observed event of catheter-guide kinked.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.
Event or Problem 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.
Event or Problem 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.
Additional Manufacturer Narrative
The initial reporter's facility name is national hospital organization kyoto medical center.Imdrf device code a0401 captures the reportable event of catheter-guide break.A flexima rx biliary stent set was received for analysis.Visual inspection found the guide catheter detached and kinked.No other problems were noted with the device.Product analysis confirmed the reported event of catheter-guide break.However, the reported event of stent difficult to position was not confirmed because this occurred during the procedure and is not possible to replicate in the laboratory of analysis.It is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied) resulted in the reported event of catheter-guide break and the observed event of catheter-guide kinked.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Correction to the initial mdr in block h6 (device codes and evaluation result codes).

• Brand Name: RX BILIARY
• Common Device Name: 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
• Report Number: 3005099803-2024-00485
• Device Sequence Number: 6336268
• Product Code: FGE
• UDI-Device Identifier: 08714729337867
• UDI-Public: 08714729337867
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K965147
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2026
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: Not provided; 03/13/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 03/14/2024; 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown