MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NEPHROSTOMY SHEATHS AND DILATORS; DILATOR, CATHETER

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

Patient Problem Sepsis (2067)

Event Date 05/01/2016

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2016.The complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Adverse event problem imdrf patient code e0306 captures the reportable event of sepsis.Imdrf impact code f2303 captures the reportable event of medication required.

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, 8/10 dilator sheath set and percutaneous access needle were used during a percutaneous nephrolithotomy (pcnl) procedure performed in (b)(6) 2016.The patient experienced sepsis and was given antibiotics.In the physician's assessment the event was not related to the imager ii, 8/10 dilator sheath set and percutaneous access needle, but was causally related to the procedure.In the physician's assessment the event was probably related to the nephromax ,but was causally related to the procedure.

• Brand Name: NEPHROSTOMY SHEATHS AND DILATORS
• Type of Device: DILATOR, CATHETER
• 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: 16706724
• MDR Text Key: 312942574
• Report Number: 3005099803-2023-01866
• Device Sequence Number: 1
• Product Code: GCC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K851144
• 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: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• 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
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Race: White