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

Model Number	M00540120
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of packaging foreign matter.
Event or Problem Description
It was reported to boston scientific corporation that an flexima nasobiliary cathter was to be used in a procedure performed on (b)(6) 2025.It was reported that there were foreign objects noted inside the inner bag (the part where the package insert is inserted).There was no patient involvement.The procedure was completed with another of the same device was used.
Additional Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of packaging foreign matter.Block h11: a nasobiliary catheter was received for analysis.Visual examination of the returned device found the device with the pouch unopened, and a foreign material was observed between the plastic bag and the product.No other damages were noted to the device.Product analysis confirmed the reported event of packaging foreign matter, as a foreign material was observed inside the packaging.Taking all available information into consideration, the investigation concluded that the most likely cause of the event is the plastic bag not being hermetically sealed, which could have allowed foreign matter to enter during storage or transportation.Therefore, the review and analysis of all available information indicated that the most probable cause is cause traced to transport/storage.
Event or Problem Description
It was reported to boston scientific corporation that an flexima nasobiliary catheter was to be used in a procedure performed on (b)(6) 2025.It was reported that there were foreign objects noted inside the inner bag (the part where the package insert is inserted).There was no patient involvement.The procedure was completed with another of the same device was used.

• Brand Name: FLEXIMA? NASOBILIARY CATHETER
• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22639867
• Report Number: 3005099803-2025-03549
• Device Sequence Number: 18565735
• Product Code: FGE
• UDI-Device Identifier: 08714729337386
• UDI-Public: (01)08714729337386(17)280304(10)35995566
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K982508
• 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): 10/21/2025

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 Model Number: M00540120
• Device Catalogue Number: M00540120
• Device Lot Number: 0035995566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2025
• 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