FDA Adverse Event Malfunction Summary report: N

BIOGLIDE

MDR report key: 1810018 · Received August 18, 2010

Report

Report Number
1810018
Event Type
Malfunction
Date Received
August 18, 2010
Date of Event
August 15, 2010
Report Date
August 17, 2010
Manufacturer
MEDTRONIC NEUROSURGERY INC.
Product Code
JXG
Product Problem
Yes
Report Source
User Facility report
Reporter Location
UT, US

Narratives

Description of Event or Problem · 1

PATIENT HAD CT SCAN, WHICH SHOWED VENTRICULOMEGALY AND DISCONNECTED CATHETER. ACUTE SHUNT MALFUNCTION RESULTING IN NEED FOR URGENT SURGERY. THE UNDERLYING CATHETER WAS SKELETONIZED USING ELECTROSURGICAL CAUTERY AND NOT CONNECTED TO THE VENTRICULAR CATHETER. THIS WAS REMOVED, WITH VALVE AND ABOUT 8 INCHES OF TUBING WITH THE REST SNAPPED OFF. WITH THE ENTIRE VENTRICULAR SYSTEM SHOWN, WE COULD NOT SEE THE VENTRICULAR CATHETER. SO AFTER A LONG LOOK AROUND WITH ENDOSCOPE, WE WERE UNABLE TO RETRIEVE THE CATHETER. COULD SEE A FAIRLY THICK MEMBRANE THAT THE CATHETER MUST HAVE FALLEN BEHIND; HOWEVER, THERE WAS A HIGHER RISK BECAUSE THERE WAS VEINS ON IT AND WAS NOT FELT TO BE WORTH OPENING THIS UP.EXTERNAL VENTRICULAR DRAIN WAS PLACED INTO THE VESTIBULE OF THE VENTRICLE BROUGHT OUT THROUGH A SEPARATE STAB INCISION.====================== HEALTH PROFESSIONAL'S IMPRESSION======================CT SCAN, SHOWED VENTRICULOMEGALY AND DISCONNECTED CATHETER, WHICH RESULTED IN NEED FOR URGENT SURGERY.====================== MANUFACTURER RESPONSE FOR VENTRICULAR SHUNT CATHETER, MEDTRONIC BIOGLIDE======================THIS IS A KNOWN PROBLEM, THE MANUFACTURER IS AWARE OF THIS PROBLEM AND HAS ISSUED A RECALL ON THIS BIOGLIDE CATHETER, (FDA RECALL #'S Z-1124-2009 TO Z-1151-2009).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BIOGLIDE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY INC. * A53850

Patients

Seq Age Sex Outcome Treatment
1 6 YR