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

Model Number	30815
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	09/01/2025
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.E1: initial reporter address 1: (b)(6) hospital.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.The patient was required to return to the hospital for device removal and replacement with a new drainage catheter.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Detailed product information was 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.The patient was required to return to the hospital for device removal and replacement with a new drainage catheter.There were no patient complications as a result of this event.It was further reported that the flexima all purpose drainage catheter was implanted on (b)(6) 2025.On (b)(6) 2025, the patient returned to the hospital to have the device exchanged for a new one as the device had fractured.

• 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: 23291874
• Report Number: 2124215-2025-71853
• Device Sequence Number: 9980558
• 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
• Report Date (Section B): 11/10/2025

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?: No
• 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
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/10/2025
• 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: 64 YR
• Patient Sex: Male