MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR HERMETIC LUMBAR CATHETER, CLOSED TIP

Catalog Number INS5010

Device Problems Difficult to Insert (1316); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This is the second report of three from the same facility and same physician."i was very used to the integra system, the only ones we used at (b)(6) where i trained.However, in the past 3 years since i came to (b)(6), i noticed a very high, almost 50%, rate of the guide wire stuck inside the lumbar drain catheter when trying to remove the guide wire after the catheter had successfully entered the intrathecal space.If trying to remove the wire, it would unravel and strip.This had "never" happened before when i was at (b)(6).This problem had compromised patient care significantly, and is a huge safety concern." "i had tried lubricating both the outside and inside (lumen) of the catheter with sterile saline, to no avail.In the last consecutive 3 cases i used the catheters, the guide wires universally got stuck despite the saline lubrication." the only thing, from the outside, that i could tell from the packages i used at (b)(6) was that the packaging looks different, smaller and may be a few non crucial parts short."this problem, as i said, has spanned across the 3-year period i have been here so may not be limited to a particular batch." additional information received on 04/20/2015 from the neurosurgeon was as follows; the issues are always found during insertion.Reason for the use: for lumbar drainage for surgical management.Procedure was hindered, at least.There was no injury involved with this issue.

Manufacturer Narrative

The device involved in the reported incident is not expected to be received for evaluation.An investigation has been initiated based upon the reported information.

• Brand Name: HERMETIC LUMBAR CATHETER, CLOSED TIP
• Type of Device: NA
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; anasco PR 00610
• Manufacturer Contact: linda serentino ; 315 enterprise drive; 6099365560
• MDR Report Key: 4742662
• MDR Text Key: 5706932
• Report Number: 2648988-2015-00039
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: INS5010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1