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

Model Number	31775
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event: date of event was approximated to (b)(6) 2024 as the exact event date was not reported.Device evaluated by mfr: the device was returned for analysis.The stent was returned.It was observed that the stent also was detached at proximal section.No other issues were identified with the device and no patient complications were reported.
Event or Problem Description
Reportable based on the device analysis completed on 25sep2024.It was reported that the stent was detached in the proximal section.An apdltl/7.3 flexima all-purpose drainage was selected for use.During the procedure, there was resistance during stent deployment, and the sheath could not be advanced.The procedure was completed with another of the same device.There were no patient complications reported.However, product investigation revealed that stent also was detached at proximal section.

• 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: 20495348
• Report Number: 2124215-2024-64267
• Device Sequence Number: 3506919
• Product Code: FFA
• UDI-Device Identifier: 08714729300670
• UDI-Public: 08714729300670
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2024

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 Expiration Date: 03/14/2026
• Device Model Number: 31775
• Device Catalogue Number: 31775
• Device Lot Number: 0031238432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2023
• 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