FDA Adverse Event Malfunction Summary report: N

INTRACRANIAL PRESSURE MONITORING KIT

MDR report key: 536250 · Received March 17, 2004

Report

Report Number
2023988-2004-00025
Event Type
Malfunction
Date Received
March 17, 2004
Report Date
March 17, 2004
Manufacturer
INTEGRA NEUROCARE LLC
Product Code
GWM
Report Source
Manufacturer report
Reporter Location
PA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THERE HAVE BEEN 3 INCIDENTS (IN 1 PT) OF CATHETER MALFUNCTION. THE RESIDENT WENT TO THE TRAUMA BAY TO INSERT A TRIPLE LUMEN BOLT SYSTEM INTO THE PT TO MONITOR ICP, PBTO2 AND BTEMP. THE PROCEDURE WENT WITHOUT A HITCH... DURA OPENED, PTO2 AND BTEMP PROBES WERE PASSED EASILY. THEN THE L-CATHETER WAS ZEROED AND WAS PASSED INTO THE BOLT SYSTEM. A WAVE FORM DID APPEAR HOWEVER, WHEN THE RESIDENT TIGHTENED THE ICP CAP, THE ICP SHOT UP TO THE 300'S (WITH NO WAVE) AND 3 RED LINES APPEARED WHERE THE ICP NUMBER SHOULD READ ON THE CAMINO. THE RESIDENT LOOSENED AND PULLED THE CATHETER OUT AND TRIED AGAIN WITH THE SAME RESULT. A SECOND L-CATHETER WAS THEN OBTAINED AND THE PROCEDURE ATTEMPTED A THIRD TIME. THE SAME RESULT OCCURRED. THIS TIME, HOWEVER, THE RED LINES DISAPPEARED AND A MESSAGE APPEARED... "NOT CONNECTED... CANNOT READ." A THIRD CATHETER WAS OBTAINED AND THE PROCEDURE ATTEMPTED FOR THE FOURTH TIME. THIS TIME THE L-CATHETER PLACEMENT WAS SUCCESSFUL; THE ICP WAVE FORM WAS GOOD AND WAS <20. LAST NIGHT (2 DAYS AFTER THE FOURTH CATHETER WAS PLACED) THIS PT'S ICP BEGAN TO TREND UPWARD. WHEN THE ICP WAS SUSTAINED ABOVE 20 THE PT WENT FOR A HEAD CT. THE CT SHOWED NO INCREASE IN SWELLING AND AN EVOLVING STROKE. IT WAS NOTED AFTER THE CT SCAN THAT THE ICP READING WAS 40-50 WITHOUT A WAVE FORM. MULTIPLE INTERVENTIONS WERE PERFORMED INCLUDING SEDATION AND MANNITOL. WHEN THE TREATING TEAM WAS STILL UNABLE TO CONTROL THE ICP THE DECISION WAS MADE TO PLACE A VENTRICULOSTOMY QUESTIONING THE VALIDITY OF THE L-CATHETER. THE OPENING PRESSURE OF THE VENTRIC WAS 9 (L-CATHETER READING WAS STILL 40-5-). DURING THE TIME OF INCREASED ICP READING FROM THE L-CATHETER, PBTO2 DID TREND DOWNWARD SOMEWHAT THOUGH NEVER APPEARED BELOW 20. CO WILL SAVE ALL THE L-CATHETERS SO THE PT TO MONITOR ICP, PBTO2 AND BTEMP. THE PROCEDURE WENT WITHOUT A HITCH... DURA OPENED, PBTO2 AND BTEMP PROBES WERE PASSED EASILY. THEN THE L-CATHETER WAS ZEROED AND WAS PASSED INTO THE BOLT SYSTEM. A WAVE FORM DID APPEAR HOWEVER, WHEN THE RESIDENT TIGHTENED THE ICP CAP, THE ICP SHOT UP TO THE 300'S (WITH NO WAVE) AND 3 RED LINED APPEARED WHERE THE ICP NUMBER SHOULD READ IN THE CAMINO. THE RESIDENT LOOSENED AND PULLED THE CATHETER OUT AND TRIED AGAIN WITH THE SAME RESULT. A SECOND L-CATHETER WAS THEN OBTAINED AND THE PROCEDURE ATTEMPTED A THIRD TIME. THE SAME RESULT OCCURRED. THIS TIME, HOWEVER, THE RED LINES DISAPPEARED AND A MESSAGE APPEARED... SAYING SOMETHING LIKE "NOT CONNECTED... CANNOT READ." A THIRD CATHETER WAS OBTAINED AND THE PROCEDURE ATTEMPTED FOR THE FOURTH TIME. THIS TIME THE L-CATHETER PLACEMENT WAS SUCCESSFUL; THE ICP WAVE WAS GOOD AND WAS <20. LAST NIGHT (2 DAYS AFTER THE FOURTH L-CATHETER WAS PLACED) THIS PT'S ICP BEGAN TO TREND UPWARD. WHEN THE ICP WAS SUSTAINED ABOVE 20 THE PT WENT FOR A HEAD CT. (THE CT SHOWED IN SWELLING AND AN EVOLVING STROKE). IT WAS NOTED AFTER THE CT SCAN THAT THE ICP READING WAS 40-50 WITHOUT A WAVE FORM. MULTIPLE INTERVENTIONS WERE PERFORMED INCLUDING SEDATION AND MANNITOL. WHEN THE TEAM WAS STILL UNABLE TO CONTROL THE ICP THE DECISION WAS MADE TO PLACE A VENTRICULOSTOMY QUESTIONING THE VALIDITY OF THE L-CATHETER. THE OPENING PRESSURE OF THE VENTRIC WAS 9 (L-CATHETER READING WAS STILL 40-50). DURING THE TIME OF INCREASED ICP READING FROM THE L-CATETHER, PBTO2 DID TREND DOWNWARD SOMEWHAT THOUGH NEVER BELOW 20.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 INTRACRANIAL PRESSURE MONITORING KIT NEURO MONITORING GWM INTEGRA NEUROCARE LLC * W049739

Patients

Seq Age Sex Outcome Treatment
1 *