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

Model Number	M001271380
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 05dec2025.A flexima all purpose drainage was returned to the quality assurance with no reported allegation.However, returned device analysis revealed a stent detached.
Additional Manufacturer Narrative
B3: date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr: the device was returned for analysis.The trocar, metal cannula, flexible cannula, the stent, the suture and the key were returned for analysis.It was possible to observed that the stent was detached at the hub section.Also, the original box was returned, and it was observed that the pouch information matches with the complaint information.

• 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: 23865374
• Report Number: 2124215-2025-92321
• Device Sequence Number: 4619415
• Product Code: FFA
• UDI-Device Identifier: 08714729323143
• UDI-Public: (01)08714729323143(17)280622(10)36819847
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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: M001271380
• Device Catalogue Number: M001271380
• Device Lot Number: 0036819847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• 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