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

Model Number	M00545560
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0401 captures the reportable event of a guide catheter break.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was implanted in the common bile duct to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the inner guide catheter broke off after deploying the stent.The broken inner guide catheter remained within the push catheter, enabling the delivery system to be removed in one piece.The stent remained implanted inside the patient.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 rx biliary stent was implanted in the common bile duct to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the inner guide catheter broke off after deploying the stent.The broken inner guide catheter remained within the push catheter, enabling the delivery system to be removed in one piece.The stent remained implanted inside the patient.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.The original pouch batch number was received; therefore, the lot expiration and device manufacture dates have been updated.Block h6: imdrf device code a0401 captures the reportable event of a guide catheter break.Block h11: a flexima biliary delivery system was returned for analysis; the stent was not returned.Visual examination of the returned device found the guide catheter detached from the inner cannula and was not inside the push catheter.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.It may be that the technique used by the physician when deploying the stent and/or the excessive force applied during pull wire retraction, limited the performance of the device and contributed to the reported event.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.

• 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: 19079757
• Report Number: 3005099803-2024-01587
• Device Sequence Number: 5870392
• Product Code: FGE
• UDI-Device Identifier: 08714729337867
• UDI-Public: 08714729337867
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2024

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: 10/04/2025
• Device Model Number: M00545560
• Device Catalogue Number: 4556
• Device Lot Number: 0030286047
• 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: 03/22/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2022
• 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