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

Model Number	M0061453520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Pain (1994)
Date of Event	07/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a percuflex ureteral stent was used during left ureteroscopic holmium laser lithotripsy and stone removal under general anesthesia and antimicrobial therapy.During the procedure, a ureteral stent was placed postoperatively to dilate the ureter and provide internal drainage to protect renal function.The patient was discharged following the procedure.However, due to pain on the affected side of the lower back and abdomen, accompanied by fever, the patient was readmitted on (b)(6) 2026, for antimicrobial therapy, and the ureteral stent was removed at a later date.The procedure was completed.Additional medical surgical intervention required.
Additional Manufacturer Narrative
Block h6: imdrf patient code e230101 and e2330 captures the reportable event of fever and pain.

• Brand Name: Percuflex
• 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: 50604424
• Report Number: 2124215-2026-47244
• Device Sequence Number: 10625507
• Product Code: FAD
• UDI-Device Identifier: 08714729040279
• UDI-Public: (01)08714729040279(17)281005(10)37630348
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K834468
• 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
• Report Date (Section B): 10/02/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: M0061453520
• Device Catalogue Number: 145-352
• Device Lot Number: 0037630348
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 10/06/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Sex: Female