MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NEPHROMAX; CATHETER, NEPHROSTOMY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Sepsis (2067); Urinary Tract Infection (2120)

Event Date 05/01/2020

Event Type  Injury  

Event 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 an imager ii, nephromax balloon, percutaneous access needle and 8/10 dilator sheath set were used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2020.The patient experienced hemorrhage, sepsis and infected perinephric hematoma, requiring transfusion, antibiotics, interventional radiology (ir) percutaneous drain placement and interventional radiology (ir) percutaneous nephrostomy tube.

Manufacturer Narrative

Date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2020.The complainant was unable to report the device suspected upn and lot number; therefore, the manufacturer date and expiration date are unknown.Imdrf patient code e0306 captures the reportable event of sepsis.Imdrf patient code e0505 captures the reportable event of hematoma.Imdrf patient code e0506 captures the reportable event of hemorrhage/blood loss/bleeding.Imdrf patient code e1310 captures the reportable event of urinary tract infection.Imdrf impact code f2302 captures the reportable event of blood transfusion.Imdrf impact code f2303 captures the reportable event of medication required.Imdrf impact code f19 captures the reportable event of surgical intervention.

• Brand Name: NEPHROMAX
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16362848
• MDR Text Key: 309393676
• Report Number: 3005099803-2023-00612
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Race: Black Or African American