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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block a2: it was reported that patient age is 51-60 years old.Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: patient code e0506 captures the reportable event of bleeding.
Event or Problem Description
It was reported a jinro pigtail nephrostomy catheter sets device was used during a percutaneous nephrostomy with percutaneous nephrolithotomy (pcnl) procedure.On (b)(6), 2024, during hospitalization and prior to discharge the patient experienced bleeding.Reportedly, there was no relationship between the adverse event and the jinro pigtail nephrostomy catheter sets device.Additionally, there was no reported malfunction or deficiency of the jinro pigtail nephrostomy catheter sets device.No intervention was required from the patient other than bedrest.There were no additional patient complications reported.
Additional Manufacturer Narrative
Block a2: it was reported that patient age is 51-60 years old.Block b3: the event date was approximated based on the procedure date.Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: patient code e0506 captures the reportable event of bleeding.
Event or Problem Description
It was reported that a nephrostomy percutaneous access set was used during a percutaneous nephrostomy with percutaneous nephrolithotomy (pcnl) procedure.On (b)(6) 2024, during hospitalization and prior to discharge the patient experienced bleeding.Reportedly, there was no relationship between the adverse event and the nephrostomy percutaneous access set.Additionally, there was no reported malfunction or deficiency of the nephrostomy percutaneous access set.The device was removed on (b)(6) 2024.No intervention was required from the patient other than bedrest.There were no additional patient complications reported.

• 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: 21123958
• Report Number: 2124215-2024-83182
• Device Sequence Number: 7463415
• Product Code: GBO
• UDI-Device Identifier: 08714729009733
• UDI-Public: 08714729009733
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• 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?: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male