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

Model Number	M001271380
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: date of event was approximated to 09/01/2025 as the exact event date was not reported.
Event or Problem Description
It was reported that suture break occurred.A 12f flexima apdl drainage catheter was selected for use.Post catheter placement, it was noted the catheter was breaking at the hub and suture area.The device was removed from the patient in one piece, and it was exchanged with a new drainage catheter.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
B3 - date of event: date of event was approximated to 09/01/2025 as the exact event date was not reported.Device eval by manufacturer: the device was not returned for analysis; however, media was provided, which shows the catheter stent break.However, it was not possible to observe the reported suture damage in the photo.The reported suture break was unable to be confirmed.
Event or Problem Description
It was reported that suture break occurred.A 12f flexima apdl drainage catheter was selected for use.Post catheter placement, it was noted the catheter was breaking at the hub and suture area.The device was removed from the patient in one piece, and it was exchanged with a new drainage catheter.There were no patient complications as a result of this event.

• 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: 23183622
• Report Number: 2124215-2025-67761
• Device Sequence Number: 9108727
• Product Code: FFA
• UDI-Device Identifier: 08714729323143
• UDI-Public: (01)08714729323143(17)280622(10)36819847
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 11/19/2025
• 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