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

Model Number	30815
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event: used the first date of the month of the aware date as no event date was provided.Detailed product information and event details were not provided to bsc.Because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.We haven't received any response yet through our good faith effort.
Event or Problem Description
It was reported that a broken hub occurred that required device replacement.A flexima all purpose drainage catheter was successfully implanted.However, the drain fractured at the hub after the patient was sent home which resulted in undesired sensations.The patient was required to return to the hospital for device removal and replacement with a new drainage catheter.
Event or Problem Description
It was reported that a broken hub occurred that required device replacement.A flexima all purpose drainage catheter was successfully implanted.However, the drain fractured at the hub after the patient was sent home which resulted in undesired sensations.The patient was required to return to the hospital for device removal and replacement with a new drainage catheter.It was further reported the tube was broken and leaking and all parts were removed from the patient.The fracture was located at the junction where the blue section of the flexima drain meets with the white section.
Additional Manufacturer Narrative
B3: date of event: used the first date of the month of the aware date as no event date was provided.Detailed product information and event details were not provided to bsc.Because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.We haven't received any response yet through our good faith effort.
Additional Manufacturer Narrative
B3: date of event: used the first date of the month of the aware date as no event date was provided.Detailed product information and event details were not provided to bsc.Because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.We haven't received any response yet through our good faith effort.Device evaluated by mfr: the flexima all purpose drainage catheter was returned for analysis.Only a section of the stent was returned for the analysis.It was observed that the hub of the stent was detached.The leak test cannot be performed due to the hub detachment.
Event or Problem Description
It was reported that a broken hub occurred that required device replacement.A flexima all purpose drainage catheter was successfully implanted.However, the drain fractured at the hub after the patient was sent home which resulted in undesired sensations.The patient was required to return to the hospital for device removal and replacement with a new drainage catheter.It was further reported the tube was broken and leaking and all parts were removed from the patient.The fracture was located at the junction where the blue section of the flexima drain meets with the white section.

• 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 DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23291801
• Report Number: 2124215-2025-71862
• Device Sequence Number: 20056202
• 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
• 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): 12/16/2025

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; 11/24/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/12/2025; 12/16/2025
• 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: 86 YR
• Patient Sex: Male