SHUNT TUNNELER

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.

Description of Event or Problem

A FACILITY REPORTED THAT DURING VENTRICULO-PERITONEAL SHUNT PLACEMENT, THE SHUNT TUNNELER (990010) HANDLE WAS STUCK. THE SURGEON HAD TO BREAK THE PLASTIC HANDLE TO CONTINUE THE PROCEDURE. THERE WAS RISK OF INJURY FOR THE PATIENT AND FOR THE SURGEON DURING BREAKAGE/DISASSEMBLY OF THE HANDLE. FACILITY ALSO STATED THERE WAS A RISK OF PNEUMOTHORAX DUE TO THE POSSIBLE 2ND IMPLANTATION OF TUNNELER. ADDITIONAL INFORMATION RECEIVED INDICATES THERE WAS INCREASED SURGERY TIME OF 15 MINUTES AND THAT THE PATIENT WAS HOSPITALIZED IN NEUROSURGERY DEPARTMENT WITH FLUCTUATING TEMPORAL-SPATIAL DISORIENTATION AND TETRAPARESIS DURING REHABILITATION. HE ALSO HAS LEFT EYE CORNEAL ABSCESS DUE TO EXPOSURE KERATITIS. THE 2ND IMPLANTATION OF TUNNELER WAS AVOIDED BY THE SURGEON.

Description of Event or Problem

N/A.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: FACILITY HAS ADVISED THAT THE PLASTIC PROTECTION COULD BE REMOVED NORMALLY. INVESTIGATION FINDINGS: SHUNT TUNNELER (990010) WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. WITHOUT DEVICE TO INVESTIGATE, COMPLAINT IS DEEMED UNVERIFIABLE AND ITS EXACT ROOT CAUSE UNDETERMINED. A POSSIBLE CAUSE OF BLOCKED HANDLE OF THE MALLEABLE TUNNELER COULD BE RELATED TO A TOO SHORT POLYAMIDE THREAD LENGTH (IF THE THREAD COULD NOT BE REMOVED, WHICH WAS NOT THE CASE AS CONFIRMED BY USER), OR RELATED TO EXCESSIVE FORCE WITH ROTATION APPLIED ON THE HANDLE WHEN INSERTED IN THE PATIENT (LEADING TO DEFORM THE CANNULA AT THE HANDLE LEVEL, BLOCKING IT). 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.