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

Model Number	M0061453510
Medical Device Problem Codes	Positioning Failure (1158); Deformation Due to Compressive Stress (2889); 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	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a percuflex ureteral stent was used during a left ureteral lithotripsy procedure, and, during implanting the stent, resistance was felt at the front end and could not be implanted smoothly, resulting to folds at the front and back end of the device.The procedure was completed with another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a040601 captures the reportable event of stent buckled material.
Event or Problem Description
It was reported that a percuflex ureteral stent was used during a left ureteral lithotripsy procedure, and, during implanting the stent, resistance was felt at the front end and could not be implanted smoothly, resulting to folds at the front and back end of the device.The procedure was completed with another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
Device code a040601 captures the reportable event of stent buckled material.Upon receipt at our quality assurance laboratory, this percuflex ureteral stent underwent a thorough analysis.Visual inspection of the device revealed that the stent buckled on both bladder and renal coils.Under magnification, it was possible to see that the renal coil tip and the suture hole were torn.Both the renal and bladder coils were kinked near the drainage hole.A functional evaluation revealed that when a sensor wire of 0.035 was inserted into the stent, some resistance was felt inside the device.The guidewire was able to fully pass through the stent, however, some resistance was felt due to the damages observed.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 the issue could be caused by operational factors.The positioner has to be loaded by the radiopaque tip of the positioner onto the guidewire and advance until it abuts stent.If the positioner was advanced with excess force over the guidewire, the stent could get buckled resulting in difficulty/unable to advance to the target site which could have caused the torn on the tip and suture hole and the kink on both coils.A conclusion code of adverse event related to procedure was assigned to this investigation.

• 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: 21308349
• Report Number: 2124215-2025-05638
• Device Sequence Number: 21044867
• Product Code: FAD
• UDI-Device Identifier: 08714729040262
• UDI-Public: 08714729040262
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K834468
• 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
• Report Date (Section B): 03/26/2025

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: M0061453510
• Device Catalogue Number: 145-351
• Device Lot Number: 0033344280
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 67 KG