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

Catalog Number INS5010

Device Problems Partial Blockage (1065); Material Fragmentation (1261); Kinked (1339); Difficult to Remove (1528); Aspiration Issue (2883)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/26/2014

Event Type  malfunction  

Event Description

The pt underwent general anesthesia nad a spinal drain placement for thoracic endovascular aortic repair (tevar).The initial spinal drain placement was uneventful.After induction and positioning for the procedure the drain was no longer draining cerebral spinal fluid (csf).Attempts to remove kinks of blockage from the system were ineffective and csf was unable to be aspirated from the catheter itself.Thus, the decision was made to replace the drain.The catheter was difficult to remove and upon removal - the catheter fractured, despite gentle traction.This occurred approximately i cm distal to the 5 marking, with an estimated 2-3 cm of catheter remaining in the intrathecal space.The retained fragment was left in place as it was deemed riskier to attempt to remove it than leave it in place.There was no evidence of injury to the pt and she was discharged without sequelae.Further info received on 04/08/2015 is as follows; was the catheter flushed to assess patency prior to placement? yes, no issues.After the lumbar catheter was placed, was there csf draining from it? yes.How much time elapsed before the catheter became blocked?.Less than 30 minutes.Please further explain what is meant by "after induction and positioning for the procedure"? the drain was placed with the pt awake and in the flexed position (spine flexed forward).Once the pt was anesthetized, she was placed in the following position.Position: supine, other.Positional aides: padded armrest, other.Explain: gel headrest under head; one blanket rolled under left flank; left arm padded and tucked in good alignment with half sheet; right arm abducted less than 90 degrees secured on padded armrest with towel and tape; lower legs in neutral alignment on tempurpedic style on ir table; safety strap across thighs.Padding: heel padding, head padding, lt.Elbow padded, rt.Elbow padded, gel pad.What method was employed to remove the blockage from the system? the anesthesia team tried flushing with a 10 ml syringe (unable to flush), repositioning the pt.They also checked for kinks in the catheter upstream, but none were found.What method was employed to remove the catheter? the catheter was removed by the attending anesthesiologist.She described that the pt was rolled on her side (still anesthetized) and the catheter was gently pulled back with steady and constant traction.There was resistance as the attending pulled back on the catheter, so she slowly continued to use steady tension.The catheter was able to be pulled back in this manner, but when the device cleared the skin, it was noted that the distal end had fractured and remained in the pt.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for eval.An investigation has been initiated based upon the reported info.

• 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: 4692937
• MDR Text Key: 5646677
• Report Number: 2648988-2015-00032
• 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: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: INS5010
• Device Lot Number: 1141923
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 90