MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES CA/USA OLM INTRACRANIAL PRESSURE MONITORING KIT; N/A

Catalog Number 1104B

Device Problems Decrease in Pressure (1490); Improper Device Output (2953)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 01/20/2017

Event Type  Injury  

Event Description

This report is in regards to the first catheter.The catheter was implanted and the intracranial pressure (icp) decreased below 0.This first catheter was thrown out.Another integra catheter was implanted (this second catheter is available to be returned).Icp also decreased below 0.The lowest measurement was -15mmhg.A competitor catheter was implanted (sophysa) and gave the right measurements.Delay of monitoring was reported to be 3 hours.At the technical site it was reported that they placed this set to the monitor.The catheter gave -3 to -2 as a zero in open air.Since then, there was no real zero changes anymore.The customer also reported that when they were tapping the connector, the value reading changed.It could be due to potentiometer issue in the connector.Linked to mfg.Report numbers: 2023988-2017-00020, 2023988-2017-00021, 3006697299-2017-00027, 3006697299-2017-00028.

Manufacturer Narrative

Additional information received on 16feb2017: there was no increase in anesthesia time.They placed a new catheter and the patient was checked in ct.The only risk to the patient was that icp was not followed due to the "miss" of an icp catheter.

Manufacturer Narrative

Integra has completed their internal investigation on (b)(6) 2017.The investigation included: methods: review of device history records.Review of complaints history.Seven lots 1104b that shipped to the customer from (b)(6) 2016 to (b)(6) 2017 met all requirements before released to fg.Complaints history; complaint history, model 110-4xxx, from (b)(6) 2016 through (b)(6) 2017 reviewed; there were four other complaints that issued with complaint code perf034, and none of them was confirmed.Conclusion: product was not returned for evaluation, no root cause could be established for the failure mode described in the customer complaint.

• Brand Name: OLM INTRACRANIAL PRESSURE MONITORING KIT
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES CA/USA; 5955 pacific center boulevard; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer (Section G): INTEGRA NEUROSCIENCES CA/USA; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6335401
• MDR Text Key: 67558706
• Report Number: 2023988-2017-00022
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K102875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1104B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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