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

Model Number	M0061602100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number, therefore, the lot expiration and device manufacture dates are unknown.Block h6: device code a0401 captures the reportable event of stent shaft break.Patient code e0306 captures the reportable event of sepsis.
Event or Problem Description
It was reported that a percuflex urinary diversion stent was implanted into the patient during a stent exchange procedure.Following the procedure, the patient was presented to the emergency room for sepsis.Imaging revealed fragmentation of the ureteral stent, with retained fragments in the ureter.The patient had a nephrostomy tube for drainage and was admitted to the intensive care unit (icu).Surgical intervention was planned for the removal of the retained stent fragments.There were no other patient complications reported.
Event or Problem Description
It was reported that a percuflex urinary diversion stent was implanted into the patient during a stent exchange procedure.Following the procedure, the patient was presented to the emergency room for sepsis.Imaging revealed fragmentation of the ureteral stent, with retained fragments in the ureter.The patient had a nephrostomy tube for drainage and was admitted to the intensive care unit (icu).Surgical intervention was planned for the removal of the retained stent fragments.There were no other patient complications reported.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number, therefore, the lot expiration and device manufacture dates are unknown.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.Block h6: device code a0401 captures the reportable event of stent shaft break.Patient code e0306 captures the reportable event of sepsis.Correction to block e4: init rptr also sent rep to fda.

• 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: 22311653
• Report Number: 2124215-2025-40735
• Device Sequence Number: 15667819
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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: M0061602100
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/12/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White