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

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

Patient Problems Sepsis (2067); Obstruction/Occlusion (2422)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

Block b3: date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2021.Block d4, h4: the complainant was unable to report the device suspected upn and 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.

Event 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 percutaneous access needle and nephromax balloon were used during a percutaneous nephrolithotomy (pcnl) procedure performed in (b)(6) 2021.The patient experienced sepsis due to obstruction.The patient undergone interventional radiology percutaneous tube placement and was readmitted.

Event 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 percutaneous access needle and nephromax balloon were used during a percutaneous nephrolithotomy (pcnl) procedure performed in (b)(6) 2021.The patient experienced sepsis due to obstruction.The patient undergone interventional radiology percutaneous tube placement and was readmitted.

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 upn and 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: 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: 16765825
• MDR Text Key: 313558083
• Report Number: 3005099803-2023-02114
• 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,Followup
• Report Date: 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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 04/25/2023
• Supplement Dates FDA Received: 05/17/2023
• 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; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Race: Native Hawaiian Or Other Pacific Islander