MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR LUMBAR DRAIN, UNSPECIFIED; N/A

Catalog Number XXX- LUMBAR DRAIN

Device Problem Obstruction of Flow (2423)

Patient Problems Staphylococcus Aureus (2058); Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

The device is not expected to be returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg.Report numbers: 2648988-2018-00094 and 2648988-2018-00095.

Event Description

This is 1 of 3 reports.Anaesthesia and intensive care published (2011) "long-term follow-up of patients with post-traumatic refractory high intracranial pressure treated with lumbar drainage." the purpose of the study was to report the experiences with external lumbar drainage (eld) in the treatment of post-traumatic high intracranial pressure (icp) and the results of the long-term follow-up in these patients.The authors undertook clinical evaluation of 30 patients with traumatic brain injury and high icp treated with second tier measures or with first-tier measures if second-tier measures were contraindicated.The study involved a retrospective review of collected data.Outcome at intensive care unit discharge and three to five years after injury were evaluated with the glasgow outcome scale.From january 2003 to december 2006 a total of 386 patients suffering from "ttraumatic" brain injury (tbi) were admitted to the intensive care unit (icu) of a third level university hospital.Intracranial pressure (icp) monitoring by means of an intraparenchymal probe (camino, integra) was performed in 160 patients.Overall, 91 patients developed increased icp.An external lumbar drain was placed by the attending intensivist in patients developing refractory high icp when the radiological conditions were present in a cranial computed tomography performed in the previous 24 hours.These included: absence of any mass lesion, discernible (present or partially compressed) basal cisterns, midline shift less than 10 mm.In the initial 17 patients, a non-tunnelled nylon epidural catheter (portex limited, hythe) was introduced through a 18 gauge curved tip needle into the subarachnoid space at l3-l4 level.In the last 13 patients, a specifically designed lumbar drainage catheter (integra) was used with the same technique.The catheter was connected to a sterile collecting system (dispomedica 22041).The collecting system was fixed at 10 to 15 cm above the foramen of monro.The mean age of patients was 34.9 +/-12.5 years and 25 (83%) were male.The median (interquartile range) glasgow coma score was 8 (7 to 10).Icp before and one hour after eld placement was 33.7 +/- 9.0 and 12.5 +/- 4.8 mmhg respectively, a decrease in 21.2 +/- 8.3 mmhg (p <0.0001).Eld was placed after a mean of 8.6 +/- 3.9 days.Cerebrospinal fluid drainage was maintained for a mean of 6.6 +/- 3.5 days.Results: icu mortality was 13% (four patients).A good outcome (moderate disability or good recovery) was found in 30% of patients at icu discharge and 62.2% of the patients in the long-term evaluation.The most common complication was eld obstruction, which occurred in eight patients (26%).It was transient in four patients but in the other four cases (13%), replacement of the eld was required.There were positive cultures of the distal end in four catheters (staphylococcus aureus in three cases and coagulase negative staphylococcus in one patient).The three cases were considered as contaminants because no positive csf culture was obtained and no clinical and analytic signs were present.In the other patient, a coagulase negative staphylococcus was also isolated in csf, and was treated with linezolid (3% total sample).No pupillary changes were recorded in the first 48 hours after eld placement.Conclusion: the use of eld resulted in a marked decrease in icp.These patients presented a good outcome in 62% of the cases in the long-term evaluation.Few complications related with eld use were noted.

Manufacturer Narrative

The article described events that occurred between 2003-2006; therefore, no device is available for failure analysis.No device history record was possible since no lot number was reported.The reported condition is unconfirmed.Since the obstruction was not associated to a device issue, and that it is a known complication in these cases due to factors other than device performance, it is concluded that the obstruction is unrelated to the device.

Event Description

N/a.

• Brand Name: LUMBAR DRAIN, UNSPECIFIED
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• MDR Report Key: 8235071
• MDR Text Key: 134584965
• Report Number: 2648988-2018-00093
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K970658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XXX- LUMBAR DRAIN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTRAPARENCHYMAL PROBE