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

Model Number	31775
Medical Device Problem Codes	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	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A 7.3 flexima all purpose drainage was selected for use.During the procedure, the stent was damaged during attempted placement over the guidewire.A tear occurred on the distal side of the stent, allowing the guidewire to exit through the side of the stent.The procedure was completed using another device of the same model without issue.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that stent damage occurred.A 7.3 flexima all purpose drainage was selected for use.During the procedure, the stent was damaged during attempted placement over the guidewire.A tear occurred on the distal side of the stent, allowing the guidewire to exit through the side of the stent.The procedure was completed using another device of the same model without issue.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
B3: used the first date of the month of the aware date as no event date was provided.The device was returned for analysis.The unit was received in a generic plastic bag.Overall visual inspection did not identify any failures or evidence that could have been affected by the decontamination process.The suture and key were returned in good condition.The metal cannula was also returned; however, it was noted to be bent.No resistance was reported during cannula removal.The drainage holes were in good condition, and the pigtail formed appropriately.No additional deformation of the device was observed.

• 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: 23853477
• Report Number: 2124215-2025-92092
• Device Sequence Number: 18649522
• Product Code: FFA
• UDI-Device Identifier: 08714729300670
• UDI-Public: (01)08714729300670(17)280220(10)35895845
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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: 31775
• Device Catalogue Number: 31775
• Device Lot Number: 0035895845
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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