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

Model Number	M001271340
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hemorrhage/Blood Loss/Bleeding (1888); Diaphoresis (2452)
Date of Event	07/21/2026
Type of Reportable Event	Malfunction

• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 50570609
• Report Number: 2124215-2026-46448
• Device Sequence Number: 15928474
• Product Code: FFA
• UDI-Device Identifier: 08714729323105
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K944290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: M001271340
• Device Catalogue Number: M001271340
• Device Lot Number: 0038699223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 09/02/2026
• Date Device Manufactured: 02/26/2026
• 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
• Patient Age: 42 YR
• Patient Sex: Female