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

Model Number	M0061453520
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Codes	Sepsis (2067); Foreign Body In Patient (2687)
Date of Event	03/03/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.Imdrf patient code e0306 captures the reportable event of sepsis.Imdrf patient code e2008 captures the reportable event of foreign body in patient.Imdrf impact code f02 captures the reportable event of death.
Event or Problem Description
It was reported that the fractured single j stent was unable to be removed at the time of stent change resulting in retained fragment with subsequent sepsis, and death.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.Imdrf patient code e0306 captures the reportable event of sepsis.Imdrf patient code e2008 captures the reportable event of foreign body in patient.Imdrf impact code f02 captures the reportable event of death.Block h11: this report is report is being submitted to correct the init rptr also sent rep to fda question (e4) section e has been change to yes.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.
Event or Problem Description
It was reported that the fractured single j stent was unable to be removed at the time of stent change resulting in retained fragment with subsequent sepsis, and death.

• Brand Name: PERCUFLEX URINARY DIVERSION STENT SET
• 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: 22198928
• Report Number: 2124215-2025-38055
• Device Sequence Number: 12673469
• Product Code: LJE
• UDI-Device Identifier: 08714729297178
• UDI-Public: (01)08714729297178
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0061453520
• Device Catalogue Number: 160-210
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/29/2025
• 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: Death
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White