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

Model Number M0067001210

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

Patient Problems Sepsis (2067); Respiratory Failure (2484)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact date is unknown; however, it was reported that the event occurred in february 2021.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Imdrf patient code (b)(6) captures the reportable event of sepsis.Imdrf patient code (b)(6) captures the reportable event of respiratory problem.Imdrf impact code (b)(6) captures the reportable event of medication required.Imdrf impact code f23 captures the reportable event of unexpected medical intervention (supplemental oxygen required).Imdrf impact code f0801 captures the reportable event of intensive care.

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 february 2021.The patient experienced sepsis and respiratory problem, requiring intensive care unit (icu), mechanical ventilation and iv antibiotics.

• Brand Name: INTRODUCER NEEDLES
• Type of Device: 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: 16369573
• MDR Text Key: 309468286
• Report Number: 3005099803-2023-00618
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 08714729077749
• UDI-Public: 08714729077749
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820867
• 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
• Device Model Number: M0067001210
• Device Catalogue Number: 700-121
• 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; Hospitalization
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Race: White