INTEGRA-HERMETIC LARGE STYLE VENTRICULAR CATHETER
Received Oct 6, 2015 · Event occurred Sep 18, 2015
Report MW5056963 · MDR key 5149399
Device
Generic name
Ventricular Catheter Set
Manufacturer
Integra NeurosciencesCatalog number
INS-4500
Lot number
1143590
Product problems
- Disconnection
- Difficult to Remove
Patient
62 YR
- Foreign Body In Patient
Narrative
Description of Event or Problem
ON (B)(6) 2015 THE PATIENT UNDERWENT A CRANIOTOMY FOR RECURRENT PITUITARY MACROADENOMA, WHEN A VENTRICULAR CATHETER WAS PLACED INTO THE RIGHT LATERAL VENTRICLE, THROUGH A SMALL PERFORATION IN THE FRONTAL BONE AT THE LEVEL OF THE CORONAL SUTURE BEHIND THE FRONTAL CRANIOTOMY USING IMAGE GUIDANCE. THE END OF THE CATHETER WAS BROUGHT THROUGH A SEPARATE SMALL INCISION 1 CM IN LENGTH. THE VENTRICULAR CATHETER WAS TRIMMED AND A LUER-LOK WAS FIXED TO THE END OF THE CATHETER AND THE LUER-LOCK WAS SUTURED TO THE SCALP. THE LUER-LOCK WAS THEN ATTACHED TO A CLOSED SYSTEM FOR EXTERNAL DRAINAGE. ON (B)(6) 2015, THE VENTRICULAR CATHETER WAS FOUND TO BE DISCONNECTED FROM THE LUER-LOK, AND WAS UNABLE TO BE RETRIEVED MANUALLY FROM THE SCALP INCISION. ON (B)(6) 2014 THE PATIENT WENT BACK TO THE OPERATING ROOM FOR RETRIEVAL OF THE DISCONNECTED VENTRICULAR CATHETER.