MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Flexima¿ APDL; tube, drainage, suprapubic

Model Number	M001271350
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that cannula break and kink occurred, requiring an additional device.The non-stenosed target lesion was located in the mildly tortuous and mildly calcified vessel.A flexima apdl drainage catheter was selected for use.The drainage catheter was placed without any issues noted during package opening, device preparation, or at the time of patient discharge.However, the patient returned three days after the procedure with a broken drain.The break was observed near the luer lock hub, at the interface where the drainage catheter meets the white component attached to the hub.The device was removed intact, and the catheter was replaced during an additional procedure.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 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela, ; CS
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 01752 ; +1(952)930-6396
• MDR Report Key: 50038381
• Report Number: 2124215-2026-40064
• Device Sequence Number: 9844301
• Product Code: FFA
• UDI-Device Identifier: 08714729323112
• UDI-Public: (01)08714729323112(17)290319(10)38886878
• 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
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M001271350
• Device Catalogue Number: M001271350
• Device Lot Number: 0038886878
• 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: 06/30/2026
• Supplement Date Received by Manufacturer: 07/30/2926
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/30/2026
• Date Device Manufactured: 03/20/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown