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

Model Number	M001274000
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the flexima device was returned for analysis.Upon examination, it was noted that the suture, key, stabilizer, stent, and flexible cannula were all included for evaluation.Bending was observed in the flexible cannula.A detached section was identified in the suture.Additionally, no resistance was encountered during the insertion and removal of the stent into the flexible cannula.
Event or Problem Description
Reportable based on device analysis completed on 30jun2025 it was reported that device difficult to advance occurred.The 50-60% stenosed target lesion was located in the moderately tortuous and mild calcified ureter.A flexima was used for procedure.During the procedure, the physician felt resistance when the catheter was pushed.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, the analysis of the returned device showed a detached suture.

• Brand Name: FLEXIMA?
• 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: 22591254
• Report Number: 2124215-2025-49857
• Device Sequence Number: 9005182
• Product Code: FAD
• UDI-Device Identifier: 08714729323754
• UDI-Public: (01)08714729323754(17)270813(10)34630288
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 07/24/2025

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: M001274000
• Device Catalogue Number: M001274000
• Device Lot Number: 0034630288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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: 68 YR
• Patient Sex: Male