MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Percuflex Plus; catheter, biliary, diagnostic

Model Number	M0061752530
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Unspecified Infection (1930); Unspecified Kidney or Urinary Problem (4503); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a150207 captures the reportable event of stent difficult to remove.
Event or Problem Description
It was reported that a percuflex plus ureteral stent was placed in a patient during a bilateral ureteral stent placement procedure.Three months following the procedure, there was recurrence of hydronephrosis and infection, and the stent was difficult to remove.No medical intervention was noted as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a150207 captures the reportable event of stent difficult to remove.Block h11: block h6 patient code has been corrected.
Event or Problem Description
It was reported that a percuflex plus ureteral stent was placed in a patient during a bilateral ureteral stent placement procedure.Three months following the procedure, there was recurrence of hydronephrosis and infection, and the stent was difficult to remove.There was no information on what have completed the procedure and there were no medical treatment or intervention reported.
Event or Problem Description
It was reported that a percuflex plus ureteral stent was placed in a patient during a bilateral ureteral stent placement procedure.Three months following the procedure, there was recurrence of hydronephrosis and infection, and the stent was difficult to remove.There was no information on what have completed the procedure and there were no medical treatment or intervention reported.
Additional Manufacturer Narrative
Block h6:\ device code a150207 captures the reportable event of stent difficult to remove.\ \ correction to blocks b1, b2 and h1.\ \ block h11: investigation analysis:\ the device was discarded; therefore, a technical analysis could not be performed.A risk review was completed and confirmed that the event of stent difficult to remove, infection, hydronephrosis (distention) were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.The impact code of insufficient information is subsequent event of the primary anticipated event.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• Brand Name: Percuflex Plus
• Common Device Name: catheter, biliary, diagnostic
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23689421
• Report Number: 2124215-2025-88198
• Device Sequence Number: 9124318
• Product Code: FAD
• UDI-Device Identifier: 08714729056812
• UDI-Public: (01)08714729056812(17)270903(10)34767481
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0061752530
• Device Catalogue Number: 175-253
• Device Lot Number: 0034767481
• Was Device Available for Evaluation?: No
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 12/03/2025; 07/03/2026; 08/17/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/26/2025; 07/28/2026; 09/10/2026
• Date Device Manufactured: 09/03/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Sex: Female