MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR HERMETIC LARGE STYLE VENTRICULAR CATHETER SET; N/A

Catalog Number INS4500

Device Problems Disconnection (1171); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/18/2015

Event Type  Injury  

Event Description

Report received from fda (mw5056963) on 04nov2015 with the following: on 2015, the patient underwent a craniotomy for recurrent pituitary macroadenoma when a ventricular catheter was placed into the right lateral ventricle through a small perforation in the frontal bone at the level of the coronal suture behind the frontal craniotomy using image guidance.The end of the catheter was brought through a separate small incision 1 cm in length.The ventricular catheter was trimmed and a luer lock was fixed to the end of the catheter and the luer lock was sutured to the scalp.The luer lock was then attached to a closed system for external drainage.On 2015, the ventricular catheter was found to be disconnected from the luer lok, and was unable to be retrieved manually from the scalp incision.On "2014", the patient went back to the operating room for retrieval of the disconnected ventricular catheter.

Manufacturer Narrative

Integra has completed their internal investigation on 12/09/2015.The investigation included: methods: review of device history records.Review of complaints history.Results: device history record (dhr) of finish good (fg) lot 1143590 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 (catheter disconnection from luer lock).The manufacturing date and expiration date for finish good (fg) lot 1143590 is 2014-10 and 2019-10, respectively.The fg lot 1143590 was released for distribution on october 30, 2014 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.Based on the information provided by the customer regarding disconnection of the luer connector from the catheter, a summary of the product¿s instructions for use (ifu) is provided below for further evaluation of the complaint.Instructions or use for ventricular catheters: slide barbed luer connector from stylet into catheter.Care should be taken not to cut or tear the tubing when placing ligatures.Slide the suture collar over the catheter to the desired position.Suture the collar to the scalp.Ventricular and lumbar catheters precautions: the silicone elastomer tubing should be carefully secured to the connector with ligatures in such a manner as to avoid cutting of the tubing.No other complaints have been reported for fg lot 1143590 regarding catheter disconnections from luer locks or any other condition.Upon review of integra¿s complaint system from january 2013 ¿ november 2015, only one (1) complaint (investigated under this report) for external ventricular drainage catheter product family (catalogs: ins-001, ins-4000, ins-4500, ins-8220, ins-8420) has been reported; approximately (b)(4) units of external ventricular drainage catheters have been shipped for distribution from 2013 to november 2, 2015, resulting in a complaint occurrence rate of approximately (b)(4).Conclusion: the condition ¿catheter disconnection from luer lock¿ could not be confirmed given that the complaint unit was not returned for evaluation.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.It was indicated in the complaint record that a luer-lock was fixed to the end of the catheter and the luer-lock was sutured to the scalp.No details were included in the report indicating if ligatures were used to secure the luer connector to the catheter and no specifics were provided on how the luer lock was sutured to the scalp.It is specified in the product¿s instructions for use that the silicone elastomer tubing should be carefully secured to the connector with ligatures in such a manner as to avoid cutting of the tubing and a suture collar be placed over the catheter and sutured to the scalp.

• Brand Name: HERMETIC LARGE STYLE VENTRICULAR CATHETER SET
• 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: 5248273
• MDR Text Key: 32100603
• Report Number: 2648988-2015-00076
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K820247
• 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: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2019
• Device Catalogue Number: INS4500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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): Required Intervention