MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION INTEGRA ACCUDRAIN EXTERNAL CSF DRAIN SYSTEM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number INS8400 W/O ANTI REFLUX VALVE IN

Device Problems Product Quality Problem (1506); Defective Component (2292); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 03/09/2021

Event Type  Injury  

Event Description

A (b)(6) yo male was admitted for endovascular repair of a 5.8cm descending thoracic aortic aneurysm.An integra lumbar spinal drain was inserted at the l4/5 interspace to allow the removal of csf and the measurement of lumbar csf pressure, and spinal cord perfusion pressure.We do this because the procedure carries a risk of spinal cord ischemia and paraplegia.The spinal drain was then connected to an integra accudrain external csf drainage system, and the anesthesiologist prepared the patient for the induction of general anesthesia.Propofol was injected through the administration port, and then they realized that the propofol had been injected through an identical port in the lumbar csf drain tubing, most of which refluxed back into the lumbar drain but several ccs were injected into the lumbar csf space via the drain.The injection was stopped, induction continued via properly identified intravenous tubing and port, and the lumbar csf drain was removed and replaced.The original unit was impounded for investigation.It is our contention that the integra accudrain is poorly designed and that the injection ports must be removed from the tubing as they represent a patient hazard.The case continued, a tevar with laser fenestration and stent for celiac and sma and chimney left renal artery stent was performed uneventfully.The patient was awakened, gross neurologic examination was intact, and they wee watched overnight.24hr after surgery, the lumbar drain was removed with no neurologic sequelae and the patient is recovering in the hospital as we write this.Fda safety report id# (b)(4).

• Brand Name: INTEGRA ACCUDRAIN EXTERNAL CSF DRAIN SYSTEM
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION ; princeton NJ 08540
• MDR Report Key: 11505893
• MDR Text Key: 240776864
• Report Number: MW5100029
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INS8400 W/O ANTI REFLUX VALVE IN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 79 YR
• Patient Weight: 92