FDA Adverse Event Injury Summary report: N

6FR SUPERTORQUE

MDR report key: 18898439 · Received March 12, 2024

Report

Report Number
MW5152806
Event Type
Injury
Date Received
March 12, 2024
Date of Event
February 23, 2024
Report Date
March 11, 2024
Manufacturer
CORDIS US CORP.
Product Code
DQO
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

INTERVENTIONAL CARDIOLOGIST WAS PERFORMING A PFO (PATENT FORAMEN OVALE) CLOSURE AND HAD A WIRE WITH A DIAGNOSTIC CATHETER IN THE LEFT ATRIUM. WHEN PROCEEDING TO DO A WIRE EXCHANGE OFF FLUOROSCOPY WITH LAB LIGHTS ON, IT WAS NOTED THAT THE STERILE FIELD WAS LITTERED WITH SMALL PLASTIC SHARDS THAT BROKE OFF FROM A 6 FRENCH CORDIS MPA DIAGNOSTIC CATHETER. THE FIELD OF CONTAMINATION INVOLVED THE ENTIRE STERILE FIELD UP TO THE SHEATH ENTERING THE BODY AS WELL AS THE PROVIDER'S HANDS. IN ADDITION, THE EQUIPMENT WAS REMOVED TO INCLUDE CATHETER, SHEATH, WIRE. GLOVES WERE EXCHANGED AND A NEW STERILE FIELD WAS CREATED ON TOP OF THE CONTAMINATED FIELD AFTER REMOVING AS MANY OF THE PARTICLES THAT COULD BE VISUALIZED. NO RETAINED PARTICLES ENTERED THE PATIENT; HAD IT ENTERED THE PATIENT, THE ENSUING RESULT WOULD HAVE BEEN STROKE AS EQUIPMENT WAS ALREADY ACTIVELY IN THE LEFT ATRIUM. THE TEAM CONTINUED THE CASE SINCE THEY WERE IN THE MIDDLE OF A CRITICAL PART OF THE PROCEDURE. THE DEFECTIVE 6 FRENCH CORDIS MPA LOT NUMBER IS 18102461. PATIENT WAS ADMITTED TO CCU (CRITICAL CARE UNIT) FOR OVERNIGHT OBSERVATION RATHER THAN PLAN DISCHARGE TO HOME. ON (B)(6) 2024, PATIENT WAS DISCHARGED HOME WITH NO ADVERSE OUTCOME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1266783 6FR SUPERTORQUE CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO CORDIS US CORP. 18102461

Patients

Seq Age Sex Outcome Treatment
1 33 YR Female Hospitalization