MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR HERMETIC LUMBAR CATHETER, CLOSED TIP; N/A

Catalog Number INS5010

Device Problems Break (1069); Kinked (1339); Difficult to Remove (1528); Device Stops Intermittently (1599)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 09/29/2015

Event Type  Injury  

Event Description

An intrathecal lumbar drain, which was originally placed under fluoroscopic guidance, stopped functioning properly.On radiograph, it was noted to be kinked.Under fluoroscopic guidance in interventional radiology, withdrew fractured catheter but remnant of catheter remains in patient from levels of t12 and l4.Additional information has been requested.Linked to sus voluntary event report number: mw5057203.

Manufacturer Narrative

Integra has completed their internal investigation on 12/15/2015.The investigation included: methods: review of device history records.Review of complaints history.Results: device history record (dhr) of finish good (fg) lot 1151743 was reviewed in order to detect any anomalies that could have occurred during the manufacturing process of the product which could have contributed and/or be related with the reported condition being investigated (fractured catheter).The manufacturing date and expiration date for finish good (fg) lot 1151743 is 2015-05 and 2019-01, respectively.The fg lot 1151743 was released for distribution on june 1, 2015 in compliance with the product specifications and integra requirements.No anomaly or discrepancies were reported during the manufacture of the fg lot that could be related to the reported condition (fractured catheter).Upon review of integra¿s complaint system from january 2013 ¿ november 2015, seven (7) complaints (including this one) for external lumbar drainage catheter product family (catalogs: ins-8330, ins-5010, nl850-8330, nl850-8430, sp0224) have been reported for ¿sheared catheter retained in patient.¿ approximately (b)(4) units of external lumbar drainage catheters have been shipped for distribution from 2013 to november 25, 2015, resulting in a complaint occurrence rate of approximately (b)(4).Conclusion: given that the complaint unit was not returned for evaluation, the reported condition (fractured catheter) could not be confirmed.No assignable causes that could be associated to the manufacturing process were determined based on review of dhr, capa's, ncr's and scar's history.According to the product¿s directions for use: ¿to avoid possible transection of the lumbar catheter, the catheter should never be withdrawn through the tuohy needle.If the catheter needs to be withdrawn, the tuohy needle and catheter (with guide wire if used) must be removed simultaneously.¿.

• Brand Name: HERMETIC LUMBAR CATHETER, CLOSED TIP
• 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
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5260530
• MDR Text Key: 32485073
• Report Number: 2648988-2015-00078
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: INS5010
• Device Lot Number: 1151743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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
• Patient Outcome(s): Other; Required Intervention