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

Model Number	M001271350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Detailed product information was not provided to bsc as the account could not provide the available information after good faith efforts.Because the product lot number is unknown, we are unable to provide the complete unique identifier (udi)#.
Event or Problem Description
It was reported the device material broke and an unretrieved device fragment caused a minor injury to the patient.During flexima? apdl device, part of the locking loop suture broke and remained inside the patient.The physician cut the flexima? apdl devic just below the hub and proceeded to pull the device out without first inserting a wire to straighten the drain.As the device was removed, the suture in the locking loop broke, resulting in a device fragment being left behind in the patient.Although the event was initially described as ongoing, additional information received through the good faith effort (gfe) process states the patient is doing well with no complications.A cardiothoracic surgeon evaluated the retained suture fragment and determined that surgical removal would pose a higher risk than leaving the fragment inside of the patient.The patient has been checked twice since the event and continues to do well without issues.

• 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 first street; propark, el coyol; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24136777
• Report Number: 2124215-2026-03930
• Device Sequence Number: 14810168
• Product Code: FFA
• UDI-Device Identifier: 08714729323112
• UDI-Public: (01)08714729323112
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/21/2026

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: M001271350
• Device Catalogue Number: M001271350
• 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: 12/24/2025
• Initial Report FDA Received Date: 01/21/2026
• 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