MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX URINARY DIVERSION STENT; CATHETER, NEPHROSTOMY

Model Number	M0061603350
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	04/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, the guidewire was unable to cross.The guidewire could not be inserted.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of cancelled / rescheduled - post sedation / sedation unknown.Imdrf device code a150205 captures the reportable event of device - difficult to advance.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable investigation results of cancelled / rescheduled - post sedation / sedation unknown.Imdrf device code a150205 captures the reportable investigation results of device - difficult to advance.Correction to block d4 based on additional information received on may 27, 2025.Block h11: the percuflex urinary diversion stent was returned with the pouch and three accessories for analysis.The reported event of device - difficult to advance will not be confirmed.During visual and magnification inspection, and wire insertion test, it was found that the stent shaft was detached.It is possible to conclude that this issue could be caused by operational factors.Probably some manipulation during the procedure could have caused detach on the device.A sensor wire was inserted into stent to evaluate if some resistance is felt inside the device, however, no resistance was felt during the analysis performed and the guidewire was able to fully pass through the stent, which cannot confirm the reported event.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 the procedure, the guidewire was unable to cross.The guidewire could not be inserted.

• Brand Name: PERCUFLEX URINARY DIVERSION STENT
• Common Device Name: CATHETER, NEPHROSTOMY
• 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: 22032475
• Report Number: 2124215-2025-30752
• Device Sequence Number: 8814997
• Product Code: LJE
• UDI-Device Identifier: 08714729821151
• UDI-Public: (01)08714729821151
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K830803
• 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): 06/20/2025

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: M0061603350
• Device Catalogue Number: 160-335
• Device Lot Number: 0035463047
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2024
• 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: Required Intervention
• Patient Sex: Unknown