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

Model Number	M00545560
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was used during an endoscopic biliary stent placement procedure in the bile duct, performed on (b)(6) 2022.During the procedure, when the physician attempted to deploy the stent, it was noted that the guide catheter was separated.Another flexima rx biliary stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Block h6: medical device problem code a0401 captures the reportable event of guide catheter break.Block h10: the returned flexima rx biliary stent was analyzed, and a visual evaluation noted that the push catheter was kinked, and the guide catheter was detached and kinked.Functional inspection could not be performed due the detachment of the guide catheter.No other problems with the device were noted.The reported event of stent failure to deploy and guide catheter separated was confirmed.Taking all available information into consideration, the investigation concluded that most likely the reported event and observed failures were due user manipulation and technique performed during procedure and/or anatomical factors.The user may have experienced difficulties during the retraction/extension of the guide catheter, this may have caused the user to apply a different technique that contributed to the kink and detachment of the guide catheter.Additionally, it is possible that the observed device damages and anatomical factors affected the correct deployment of the stent during the retraction of the guide catheter.Therefore, the most probable root cause is adverse event related to the procedure.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was used during an endoscopic biliary stent placement procedure in the bile duct, performed on (b)(6) 2022.During the procedure, when the physician attempted to deploy the stent, it was noted that the guide catheter was separated.Another flexima rx biliary stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.

• 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: 15982132
• Report Number: 3005099803-2022-07139
• Device Sequence Number: 17873246
• Product Code: FGE
• UDI-Device Identifier: 08714729337867
• UDI-Public: 08714729337867
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2023

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: 10/03/2024
• Device Model Number: M00545560
• Device Catalogue Number: 4556
• Device Lot Number: 0028137917
• 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: 11/14/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• 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