MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Flexima APDL; tube, drainage, suprapubic

Model Number	30975
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Obstruction of Flow (2423); Deformation Due to Compressive Stress (2889); Positioning Problem (3009)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drainage catheter was difficult to remove.A 6 french flexima apdl was selected for use to drain a biliary abscess.The drainage catheter was inserted into the patient, but the drain could not be released.The plastic cannula folded back on itself like an accordion when the internal metal component was pulled.The drain, therefore, could not be used as the lumen was covered by the internal metal part.Removal of the drain was difficult because of the accordion like damage, and resulted in pain during removal.A new drain was successfully inserted.There were no further patient complications as a result of the event.

• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 23468127
• Report Number: 2124215-2025-74655
• Device Sequence Number: 8791088
• Product Code: FFA
• UDI-Device Identifier: 08714729323082
• UDI-Public: (01)08714729323082(17)271004(10)34997436
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K944290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: 30975
• Device Catalogue Number: 30975
• Device Lot Number: 0034997436
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• 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