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

Model Number	30815
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 - date of event: event date not reported and estimated based on aware date.
Event or Problem Description
It was reported that the hub separated which required an additional device.A flexima all purpose drainage catheter was selected for use.The device was successfully placed in the patient, and the patient was discharged home.However, the hub separated and the patient was required to return to the hospital for a device replacement.The drainage catheter was successfully removed, and a new device was implanted.There were no patient complications as a result of the event.
Event or Problem Description
It was reported that the hub separated which required an additional device.A flexima all purpose drainage catheter was selected for use.The device was successfully placed in the patient, and the patient was discharged home.However, the hub separated and the patient was required to return to the hospital for a device replacement.The drainage catheter was successfully removed, and a new device was implanted.There were no patient complications as a result of the event.It was further reported that the tube appeared to be broken and was removed from the patient intact.The fracture was observed at the junction where the blue section of the flexima drain meets with the white section.The drainage catheter was placed less than 48 hours.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Only a section of the stent was returned for the analysis.It was observed that the hub and the middle of the stent were detached, also the suture was detached.
Event or Problem Description
It was reported that the hub separated which required an additional device.A flexima all purpose drainage catheter was selected for use.The device was successfully placed in the patient, and the patient was discharged home.However, the hub separated and the patient was required to return to the hospital for a device replacement.The drainage catheter was successfully removed, and a new device was implanted.There were no patient complications as a result of the event.It was further reported that the tube appeared to be broken and was removed from the patient intact.The fracture was observed at the junction where the blue section of the flexima drain meets with the white section.The drainage catheter was placed less than 48 hours.

• Brand Name: FLEXIMA APD
• 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: 23316428
• Report Number: 2124215-2025-73943
• Device Sequence Number: 20080787
• Product Code: FFA
• UDI-Device Identifier: 08714729323129
• UDI-Public: (01)08714729323129
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K944290
• 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,Followup
• Report Date (Section B): 12/09/2025

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: 30815
• Device Catalogue Number: 30815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: 10/14/2025; 11/18/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/10/2025; 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 77 YR
• Patient Sex: Female