MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA APDL; TUBE, DRAINAGE, SUPRAPUBIC

Model Number	30975
Medical Device Problem Codes	Difficult to Insert (1316); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: device evaluation by manufacturer: unit returned in a generic plastic bag; overall visual inspection did not identify failures or evidence that could be lost due to decontamination process.The stent, the suture and the metal cannula were returned for analysis.It was possible to observed that the metal cannula was detached and kinked inside the stent, moreover the suture was detached.The functional test could not be passed because the metal cannula could not be advanced due to the detached and kinked inside the stent.
Event or Problem Description
Reportable based on device analysis completed on 15oct2025.It was reported that the device did not function as expected.A flexima all purpose drainage catheter was selected for use in a procedure.During the procedure, the flexima all purpose drainage catheter was damaged and did not function as expected.A different device of the same model was used to complete the procedure.There were no patient complications as a result of this event.However, device analysis revealed the device material separated and detached.

• Brand Name: FLEXIMA APDL
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23417252
• Report Number: 2124215-2025-77271
• Device Sequence Number: 18375053
• Product Code: FFA
• UDI-Device Identifier: 08714729323082
• UDI-Public: (01)08714729323082(17)251012(10)30340545
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K944290
• 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
• Report Date (Section B): 10/29/2025

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: 10/12/2025
• Device Model Number: 30975
• Device Catalogue Number: 30975
• Device Lot Number: 0030340545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2022
• 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