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

Model Number	M001275030
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent broke.On (b)(6) 2025, a 7.3 flexima all-purpose drainage catheter was selected for percutaneous liver abscess drainage.However, the following day, it was noted through the computerized tomography (ct) that the tube had come off within the liver.Subsequently, on (b)(6) 2025, the tube stent was removed.The pigtail was not straightened, so the tube was removed while straightening it with a guidewire.The suture seemed to get caught on something and could not be pulled out, so the procedure was unavoidably completed with a remaining suture inside the body, approximately 2cm from the body surface.On (b)(6) 2025, the suture was completely pulled inside the patient when visually checked.At this time, there were no adverse effects to the patient.As per physician, it is possible that a structure was formed within the liver and the suture may have been caught there.However, the physician doubted that a structure could be formed so quickly because it has not been long since it was placed.There were no patient complications reported.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21323295
• Report Number: 2124215-2025-05235
• Device Sequence Number: 15627489
• Product Code: FFA
• UDI-Device Identifier: 08714729300694
• UDI-Public: 08714729300694
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2025

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: M001275030
• Device Catalogue Number: M001275030
• 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: 01/15/2025
• Initial Report FDA Received Date: 02/06/2025
• 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