SHUNT TUNNELER

Description of Event or Problem

A FACILITY REPORTED THAT DURING VENTRICULO PERITONEAL SHUNT SURGERY, THE BLUE HANDLE OF THE SHUNT TUNNELER (990010) WHICH IS TO BE EXPLANTED FROM THE VALVE GUIDE WAS STUCK. THE DEVICE WAS ALREADY INTRODUCED UNDER THE PATIENT'S SKIN FROM HEAD TO ABDOMEN WHEN THE ISSUE HAPPENED. THE SURGEON HAD TO APPLY FORCE TO TAKE IT OUT WHICH TWISTED THE TUNNELER. THEY UNTWISTED THE SYSTEM AFTER, THE TUNNELER WAS TORN, AND THERE WAS RISK OF INJURY FOR PATIENT AND SURGEON. NO INJURY WAS REPORTED. THERE WAS INCREASED SURGERY TIME OF 15 MINUTES.

Additional Manufacturer Narrative

AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

SHUNT TUNNELER (990010) WAS NOT RETURNED FOR EVALUATION AS THE PRODUCT WAS DISCARDED AS PER CUSTOMER; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.