MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NEPHROSTOMY CATHETER SETS; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number	M0064201110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block a2: the patient was reported to be more than 80 years old.Block b3: the event date was approximated based on the procedure date.Blocks 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: imdrf patient code e1310 captures the reportable event of urinary tract infection.Imdrf impact code f12 captures the reportable event of serious injury.
Event or Problem Description
It was reported that a nephrostomy catheter set was used to establish percutaneous nephrostomy access during a percutaneous nephrostomy procedure performed on (b)(6) 2025.Following hospital discharge, the patient developed a urinary infection during the catheter indwelling period.No additional adverse events were reported.Per physician's assessment, the event was not related to the device.

• Brand Name: NEPHROSTOMY CATHETER SETS
• Common Device Name: CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 first street, propark; el coyol; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21352924
• Report Number: 2124215-2025-03631
• Device Sequence Number: 13001690
• Product Code: GBO
• UDI-Device Identifier: 08714729009733
• UDI-Public: 08714729009733
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K820867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2025

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: M0064201110
• Device Catalogue Number: 420-111
• 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: 01/13/2025
• Initial Report FDA Received Date: 02/11/2025
• 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: Other
• Patient Sex: Male