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

Model Number	M0061752730
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a24 captures the reportable investigation results of stent shaft break.Block h11: the percuflex plus ureteral stent was returned with the pouch and the positioner for product analysis, however the suture did not return.During the visual inspection, and device inspection under magnification, it was found that the stent shaft detached in two parts.It is possible that the retrieval line may be removed before placement at the physician's discretion.If the retrieval line gets entangled in the coil and is removed using excess force, the stent can get detached or separated during the procedure affecting the performance of the device.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure, since the adverse event occurred during the procedure and the device had no influence on the event.
Event or Problem Description
It was reported that during insertion, the stent could not be placed due to a problem with the stent advancer.The procedure was completed with another of the same device and the patient condition following procedure was stable.

• 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: 22548344
• Report Number: 2124215-2025-48395
• Device Sequence Number: 8727111
• Product Code: FAD
• UDI-Device Identifier: 08714729041207
• UDI-Public: (01)08714729041207(17)261129(10)32961454
• 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
• Report Date (Section B): 07/18/2025

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: M0061752730
• Device Catalogue Number: M0061752730
• Device Lot Number: 0032961454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2023
• 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: Male
• Patient Weight: 65 KG