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

Model Number	M001271340
Medical Device Problem Codes	Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 14nov2025.It was reported that catheter was blocked.A flexima apdl was selected for use.During the procedure, it was noted that the catheter was blocked and the liquid could not be drawn out.The procedure was completed with a different device.There were no patient complications as a result of this event.However, device analysis revealed the tip of the trocar perforated the stent, and part of the tip is visible through the hole.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device evaluated by mfr: the stent, trocar, metal cannula, and flexible cannula were returned for analysis.The trocar and the metal cannula were returned inside the stent.It was observed that the tip of the trocar perforated the stent, and part of the tip is visible through the hole.Additionally, the flexible cannula was bent.A functional test was performed, inserting a metal cannula and the trocar.When advancing it through the stent, no resistance was felt, the pig's tail was also well shaped.No other issues were identified during the product analysis.

• 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: 23790542
• Report Number: 2124215-2025-86940
• Device Sequence Number: 18761110
• Product Code: FFA
• UDI-Device Identifier: 08714729323105
• UDI-Public: (01)08714729323105(17)260921(10)32487144
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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 Expiration Date: 09/21/2026
• Device Model Number: M001271340
• Device Catalogue Number: M001271340
• Device Lot Number: 0032487144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 65 KG