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

Model Number	M00539290
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Difficult to Advance (2920); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
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 investigation findings of guide catheter break.Block h11: a flexima biliary stent was received for analysis.Visual and microscopic examination of the returned device found that the guide catheter was kinked, stretched and detached; the push catheter suture hole was torn, and the stent had a foreign material at distal section (possibly a tissue residue of the procedure).No other problems were noted with the stent and delivery system.Product analysis confirmed the reported events of stent difficult to advance, catheter guide kinked, and stent failure to deploy.Taking all available information into consideration, the investigation concluded that the reported events and observed damages were likely due to factors encountered during the procedure such as the physician's technique, and the force applied to the guide catheter cap, which limited the performance of the device and contributed to the reported events and observed problems.Therefore, 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 was to be implanted in the bile duct to treat a choledocholithiasis during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on an unknown date.During the procedure, the catheter rolled up and the stent could not be inserted.A different device was used to complete the procedure.There were no patient complications reported as a result of this event.Note: this complaint has been deemed mdr reportable event based on the investigation result which revealed that the guide catheter was detached.Please see block h11 for the full investigation details.

• Brand Name: FLEXIMA 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: 20423643
• Report Number: 3005099803-2024-05014
• Device Sequence Number: 7608666
• Product Code: FGE
• UDI-Device Identifier: 08714729162605
• UDI-Public: 08714729162605
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2024

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: 08/21/2025
• Device Model Number: M00539290
• Device Catalogue Number: 3929
• Device Lot Number: 0029996428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2022
• 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