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
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2021, as no exact date was reported.The complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient code e0306 captures the reportable event of sepsis.Imdrf patient code e2328 captures the reportable event of obstruction.Imdrf impact code f08 captures the reportable event of hospitalization.Imdrf impact code f19 captures the reportable event of surgical intervention.
Event or Problem Description
It was reported to boston scientific corporation that a percutaneous access needle was used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2021.The patient experienced sepsis /obstruction and required readmission/ir perc tube placement.
Additional Manufacturer Narrative
Block b3: date of event: the exact date is unknown; however, it was reported that the event occurred in february 2021.Block d4, h4: the complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf patient codes e0306 and e2328 capture the reportable event of sepsis and obstruction.Imdrf impact codes f08 and f19 capture the reportable event of hospitalization and surgical intervention.Block h11: correction: block b5 (describe event or problem) and h10 (additional mfr narrative).
Event or Problem Description
It was reported to boston scientific corporation that a percutaneous access needle was used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2021.The patient experienced sepsis /obstruction and required readmission/ir perc tube placement.Additional information was received on march 20, 2023: it was clarified that the patient experienced sepsis due to obstruction.The patient undergone interventional radiology percutaneous tube placement and was readmitted.
Additional Manufacturer Narrative
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 report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.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 f08 captures the reportable event of hospitalization.Imdrf impact code f19 captures the reportable event of surgical intervention.
Event or Problem Description
It was reported that a percutaneous access needle was used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2021.The patient experienced sepsis /obstruction and required readmission/ir perc tube placement.
Event or Problem Description
It was reported to boston scientific corporation that a percutaneous access needle was used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2021.The patient experienced sepsis /obstruction and required readmission/ir perc tube placement.Additional information was received on march 20, 2023: it was clarified that the patient experienced sepsis due to obstruction.The patient undergone interventional radiology percutaneous tube placement and was readmitted.
Additional Manufacturer Narrative
Block b3: date of event: the exact date is unknown; however, it was reported that the event occurred in february 2021.Block d4, h4: the complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Block h2: additional information: block a6 (race) has been updated based on the additional information received on april 25, 2023.Block h6: imdrf patient codes e0306 and e2328 capture the reportable event of sepsis and obstruction.Imdrf impact codes f08 and f19 capture the reportable event of hospitalization and surgical intervention.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16375784
• Report Number: 3005099803-2023-00616
• Device Sequence Number: 7258807
• 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,Followup,Followup
• Report Date (Section B): 05/17/2023

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: 03/20/2023; 04/19/2023; 04/25/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 04/17/2023; 04/20/2023; 05/17/2023
• 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: Native Hawaiian Or Other Pacific Islander