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

Model Number	M00539200
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	01/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was to be used to treat bile duct obstruction secondary to biliary stones during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During preparation and outside the patient, it was found that the push catheter was fractured.The procedure was completed with another of the same device.There was no patient complication reported as a result of this event.The patient condition following the procedure was reported to be stable.Note: this complaint has been deemed mdr reportable based on the investigation result which revealed the catheter guide was broken.
Additional Manufacturer Narrative
Block h6: mdrf device code a0401 captures the reportable investigation result of catheter guide break.Block h11: a flexima biliary preloaded stent was received for analysis.Visual inspection found the guide catheter and the suture were detached, and the push catheter suture hole was torn.No other damages were noted to the device.Product analysis could not confirm the reported event of push catheter break.However, the investigation found the catheter guide was detached.The investigation concluded that the observed damage was most likely due to the manner how the device was manipulated prior to the procedure.According to the solo pack inspection step#2, any cosmetic defects should have been detected and scrapped before sealing the device into the package.Therefore, a review and analysis of all available information indicate the most probable cause of the event is adverse event related to procedure.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21778581
• Report Number: 3005099803-2025-01408
• Device Sequence Number: 8664415
• Product Code: FGE
• UDI-Device Identifier: 08714729337362
• UDI-Public: (01)08714729337362(17)250124(10)28743676
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 04/04/2025

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: 01/24/2025
• Device Model Number: M00539200
• Device Catalogue Number: M00539200
• Device Lot Number: 0028743676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2022
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 85 KG