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

Model Number	M001271380
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).B3: date of event: used the first date of the month of the aware date as no event date was provided additional event and patient details were not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.If additional details become available, a supplemental report will be submitted.
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, within one week it was observed that the drainage catheter broke at the hub which resulted in pain.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, within one week it was observed that the drainage catheter broke at the hub which resulted in pain.The patient was required to return to the hospital for device removal and replacement with a new drainage catheter.It was further reported that no pain and discomfort was felt by the patient, and the device was exchanged for a new drain.It was noted that there was no difficulty changing the drainage catheter because they would usually be cut.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) medical center.B3: date of event: used the first date of the month of the aware date as no event date was provided.Additional event and patient details were not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.If additional details become available, a supplemental report will be submitted.

• Brand Name: FLEXIMA? APDL
• 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: 23110947
• Report Number: 2124215-2025-66342
• Device Sequence Number: 9832631
• Product Code: FFA
• UDI-Device Identifier: 08714729323143
• UDI-Public: (01)08714729323143(17)280415(10)36316407
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K944290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M001271380
• Device Catalogue Number: M001271380
• Device Lot Number: 0036316407
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 10/20/2025
• Date Device Manufactured: 04/16/2025
• 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
• Patient Sex: Unknown