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

Model Number	M0064201110
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a nephrostomy catheter set was used to establish percutaneous nephrostomy access and urine drainage during a percutaneous nephrostomy procedure performed on (b)(6) 2024.Following the procedure, the patient pulled on tube post procedure and dislodged it from collecting system.The catheter was removed on (b)(6) 2024.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block a2: the patient was reported to be between 61-70 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 device code a051201 captures the reportable event of catheter dislodgement.

• 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 calle primera; el coyol; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21260279
• Report Number: 2124215-2025-03682
• Device Sequence Number: 12781239
• Product Code: GBO
• UDI-Device Identifier: 08714729009733
• UDI-Public: 08714729009733
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2025

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: 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: 01/06/2025
• Initial Report FDA Received Date: 01/28/2025
• 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
• Patient Sex: Male