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

Model Number	M001271810
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because some of the specific product details are unknown, we are unable to provide some of the specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that hub detachment occurred.A flexima was selected for use.The nephrostomy tube was placed on (b)(6) 2025.Fifteen days post procedure, the patient returned because the nephrostomy tube was separated from the hub.The tube was removed, and it was replaced with a new nephrostomy tube.There were no patient complications as a result of this event and the patient fully recovered.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was not returned for analysis.However, a photo was provided from the healthcare facility.The photo showed a nephrostomy device, and it was possible to observe the catheter detached from the stopcock.This concludes the product analysis.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because some of the specific product details are unknown, we are unable to provide some of the specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that hub detachment occurred.A flexima was selected for use.The nephrostomy tube was placed on (b)(6) 2025.Fifteen days post procedure, the patient returned because the nephrostomy tube was separated from the hub.The tube was removed, and it was replaced with a new nephrostomy tube.There were no patient complications as a result of this event and the patient fully recovered.

• Brand Name: FLEXIMA?
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23767294
• Report Number: 2124215-2025-86747
• Device Sequence Number: 18790142
• Product Code: GBO
• UDI-Device Identifier: 08714729323327
• UDI-Public: (01)08714729323327
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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: M001271810
• Device Catalogue Number: M001271810
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/05/2026
• 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