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

Model Number	M001274020
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent was buckled, resulting in subsequent device explant.A flexima? device was selected for use in a left antegrade ureteric stenting procedure.The patient was numbed using local anesthesia.During the procedure, the stent was able to be implanted with difficulty, but was shown to have buckled, and was protruding from the nephrostomy site.The physician performed multiple retrieval attempts with a snare to reposition the stent , but was ultimately unsuccessful.The index procedure was cancelled.On august 04, 2026, the patient underwent an additional procedure to retrieve the stent and implant a new stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital detailed product information was provided to bsc, but was unable to be verified.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.

• 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 Limited; ballybrit business park; galway ; EI
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 50774539
• Report Number: 2124215-2026-49142
• Device Sequence Number: 9472494
• Product Code: FAD
• UDI-Device Identifier: 08714729323778
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: M001274020
• Device Catalogue Number: M001274020
• Device Lot Number: 37092396
• 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: 08/17/2026
• Initial Report FDA Received Date: 09/15/2026
• 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