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

Model Number	M0067001210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Sepsis (2067); Obstruction/Occlusion (2422)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Note: this report pertains to one of two devices used in the same patient and procedure.It was reported to boston scientific corporation that a nephromax balloon and a percutaneous access needle were used during a percutaneous nephrolithotomy procedure performed in february 2021.The patient experienced sepsis and dislodgement of nephrostomy tube with obstruction, requiring readmission with left interventional radiology (ir) percutaneous nephrostomy tube and antibiotics.
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2021, as no exact date was reported.The complainant was unable to provide the suspected device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).
Additional Manufacturer Narrative
Correction to block g1 mfr site address 1.Block b3: date of event was approximated to february 1, 2021, as no exact date was reported.Block d4, h4: the complainant was unable to provide the suspected device lot number; therefore, the lot expiration and device manufacture dates are unknown.Detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf patient code e0306 captures the reportable event of sepsis.Imdrf patient code e2328 captures the reportable event of obstruction.Imdrf impact code f2303 captures the reportable event of medication required.Imdrf impact code f08 captures the reportable event of hospitalization.Imdrf impact code f2301 captures the reportable event of additional device required.
Event or Problem Description
Note: this report pertains to one of four devices used in the same patient and procedure.It was reported to boston scientific corporation that a nephromax balloon and a percutaneous access needle were used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2021.The patient experienced sepsis and dislodgement of nephrostomy tube with obstruction, requiring readmission with left interventional radiology (ir) percutaneous nephrostomy tube and antibiotics.

• Brand Name: INTRODUCER NEEDLES
• 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 16369180
• Report Number: 3005099803-2023-00631
• Device Sequence Number: 7993184
• Product Code: GBO
• UDI-Device Identifier: 08714729077749
• UDI-Public: 08714729077749
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: M0067001210
• Device Catalogue Number: 700-121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Race: Black Or African American