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

Model Number	M00545560
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of a guide catheter break.Imdrf impact code f2301 captures the reportable event of the guide catheter being removed using forceps.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent and naviflex rx delivery system were to be used in the bile duct during a biliary stent implantation procedure performed on an unknown date.During the procedure, the stent was inserted along the guidewire to the target site and released.The endoscope screen was checked after release, and it was noticed that the inner catheter had been separated and remained inside the stent; therefore, it was removed with forceps.The stent was then repositioned, and the procedure was completed.There were no patient complications reported as a result of the event.Note: no further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of a guide catheter break.Imdrf impact code f2301 captures the reportable event of the guide catheter being removed using forceps.Block h11: a flexima biliary delivery system was received for analysis; however, the guide catheter and the stent were not returned.Visual examination of the returned device found the push catheter kinked.No other damages were noted.The reported event of guide catheter break was confirmed.Taking all available information into consideration, the investigation concluded that the reported event was likely due to factors encountered during the procedure.Most likely there was difficulty deploying the stent and the amount of pressure applied to deploy it could have damaged the guide catheter, getting it detached from the pull wire.In addition, the push catheter was found kinked.It is possible that during the process of inserting the device into the scope, the pressure applied to the device contributed to the damage noted to the push catheter.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent and naviflex rx delivery system were to be used in the bile duct during a biliary stent implantation procedure performed on an unknown date.During the procedure, the stent was inserted along the guidewire to the target site and released.The endoscope screen was checked after release, and it was noticed that the inner catheter had been separated and remained inside the stent; therefore, it was removed with forceps.The stent was then repositioned, and the procedure was completed.There were no patient complications reported as a result of the event.Note: no further information has been obtained despite good faith efforts.

• 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: 19131053
• Report Number: 3005099803-2024-01773
• Device Sequence Number: 20581498
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00545560
• Device Catalogue Number: 4556
• Device Lot Number: 0033017686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown