MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE; N/A

Catalog Number INS8400

Device Problems Improper Device Output (2953); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 03/13/2016

Event Type  Injury  

Event Description

This is the first of three reports.It was reported that on (b)(6) 2016, two accudrain systems ins8400 were connected to two ins8420 catheters and used to perform bilateral subdural drainage for treatment of chronic subdural hematoma.The patient was stable but at the end of the second day, his condition worsened.Ct scan showed bilateral subdural collections of air.Both accudrain systems were filled with air after the drainage pressure was lowered.The surgeon then performed a second surgery to remove the subdural air collections.The patient was again stable with two new accudrain systems for the bilateral subdural drainage.Additional information was received on 29mar2016: it was verified that the date the patient's condition worsened (end of 2nd day) was on (b)(6) 2016.The date of the ct scan that showed the bilateral subdural collections of air was also on (b)(6) 2016 as well as the date of the surgery to remove the subdural air collections.Linked to mfg.Report numbers: 2648988-2016-00017 and 2648988-2016-00019.

Manufacturer Narrative

Integra has completed their internal investigation on 14apr2016.Methods: review of dhr.Review of complaint history.Results: the device was not returned for evaluation (destroyed by the customer).Three complaints are evaluated in one investigation since they are part of a single event in which different components were involved.The customer identified accudrain without the anti-reflux valve and traumacath, 35 cm as the products involved in the event.Mfg#2648988-2016-00018, lot# 1151195, catalog#ins-8400, release date:05/07/2015.Mfg#2648988-2016-00019, lot# 1153189, catalog#ins-8400, release date:10/13/2015.Mfg#2648988-2016-00017, lot#1154437, catalog#ins-8420, release date:01/28/2016.No unusual events were noticed during dhr review of the mentioned lots.Each of them complied with their respective in-process and release criteria.The lots after complying with all their respective requirements were released by qa.Review of product's complaint history from march 2014 - march 2016.There has not been any other complaint opened to any of the three (3) lots reported.Accudrain product family: upon review of integra's complaint system from march 2014 to march 2016, there is no other complaint related to ¿bilateral subdural collections of air¿ for external drainage (accudrain) product family.The calculated complaint occurrence rate (b)(4) external drainage catheters (ventricular) product group: upon review of integra's complaint system from march 2014 to march 2016, there is no other complaint related to ¿bilateral subdural collections of air¿ for external drainage catheters (ventricular) product group.The calculated complaint occurrence rate (b)(4).Conclusion: given that the complaint units were not returned for evaluation, the reported condition could not be confirmed.The root cause in this event is undetermined although it could be related to an off-label use of the product.The devices were used to perform bilateral subdural drainage (for treatment of chronic subdural hematoma).This type of procedure is an off-label use for accudrain and the traumacath as subdural drainage is not an indication or intended use found in products¿ ifu.

• Brand Name: ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE
• 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: 5567238
• MDR Text Key: 42420161
• Report Number: 2648988-2016-00018
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K042825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: INS8400
• Device Lot Number: 1151195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2015
• 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): Required Intervention