MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX? PLUS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M0061752630
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a percuflex plus ureteral stent was to be used in a right-sided ureteroscopy-ureteral stent replacement procedure.During unpacking, it was found that the stent was damaged.The procedure was not completed due to this event and there were no patient complications reported.This event is being reported for canceled/rescheduled procedure.Procedure with a patient under anesthesia or sedation status unknown.
Additional Manufacturer Narrative
Block e1: initial reporter address 1 (b)(6) hospital.Block h6: impact code f1001 captures the reportable event of canceled/rescheduled procedure.
Event or Problem Description
It was reported that a percuflex plus ureteral stent was to be used in a right-sided ureteroscopy-ureteral stent replacement procedure.During unpacking, it was found that the stent was damaged.The procedure was not completed due to this event and there were no patient complications reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.Additional information was received on december 01, 2025, with an attached photo of the complaint device showing that the coil was detached, and stating that, the procedure has been completed with another of the same device on the rescheduled date on september 18, 2025.
Additional Manufacturer Narrative
(b)(6).Impact code f1001 captures the reportable event of canceled/rescheduled procedure.Blocks b5, and e1 have been updated based on the additional information received on december 01, 2025.
Additional Manufacturer Narrative
Block e1: initial reporter address 1 (b)(6).Block h6: impact code f1001 captures the reportable event of canceled/rescheduled procedure.Block h11: investigation analysis.Upon receipt at our quality assurance laboratory, this percuflex plus ureteral stent underwent a thorough analysis.Visual analysis of the returned device identified that the bladder coil was detached.The suture was returned uncut and loaded, and the suture hole was torn, which were also confirmed by the visual and microscopic inspection of the media provided by the customer.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.Based on the information available and analysis results, it is possible to conclude that this issue could be caused by operational factors.The retrieval line may be removed before placement at the physician's discretion, and if the retrieval line gets entangled in the bladder coil and is removed using excess force, the stent can get detached/separated and torn during the procedure, affecting the performance of the device.A conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that a percuflex plus ureteral stent was to be used in a right-sided ureteroscopy-ureteral stent replacement procedure.During unpacking, it was found that the stent was damaged.The procedure was not completed due to this event and there were no patient complications reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.Additional information was received on december 01, 2025, with an attached photo of the complaint device showing that the coil was detached, and stating that, the procedure has been completed with another of the same device on the rescheduled date on (b)(6), 2025.

• 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: 23639447
• Report Number: 2124215-2025-85978
• Device Sequence Number: 13062398
• Product Code: FAD
• UDI-Device Identifier: 08714729041184
• UDI-Public: (01)08714729041184(17)270905(10)34786860
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K924608
• 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,Followup,Followup
• Report Date (Section B): 02/23/2026

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: M0061752630
• Device Catalogue Number: M0061752630
• Device Lot Number: 0034786860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 12/01/2025; 01/27/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/24/2025; 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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 Age: 36 YR
• Patient Sex: Male
• Patient Weight: 70 KG