MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER; LICOX BOLTS CATHETERS & KITS

Catalog Number IP1P

Device Problems Disconnection (1171); Improper Device Output (2953)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2018

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is not expected to be received for evaluation.An investigation has been initiated based upon the reported information.

Event Description

It was reported that on (b)(6) 2018, the ip1p probe (kit containing cc1.P1 and the ip1 introducer) was found unscrewed; disconnection was at the level of the monitor, 3 days after insertion.The probe worked normally and correctly until the disconnection.The probe was disconnected only a few seconds because the issue was detected immediately by medical employees.The probe was then screwed and connected but the value of oxygen (ptio2) measured was not correct.The medical team waited until the next day to conclude that the probe was not working.They stopped the monitoring with the probe due to the incorrect values.

Manufacturer Narrative

No product was not available for investigation.The device was discarded at the hospital.No device traceability information was provided; hence no device history records review could be performed.The reported complaint was not confirmed.From the available information, the licox probe ref ip1p functioned correctly during 3 days, then the probe connector was disconnected from the cable, reconnected rapidly but the oxygen pressure measures were no more as expected.For connection, the probe connector and cable are securely clipped together, therefore an erroneous manipulation could explain the disconnection after 3 days of correct function of the licox system.After reconnection, a stabilization time may be required before retrieving the correct values.From the available information, reconnection was made very rapidly and the surgeon waited a few hours before concluding the probe was not providing correct values.The following other hypothesis may explain a modification of the measured values: a displacement of the probe if disconnection is related to an excessive traction; and a modification of anode and cathode positions linked to an excessive traction.The exact root cause of the incorrect measured values after reconnection could not be determined.

• Brand Name: KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER
• Type of Device: LICOX BOLTS CATHETERS & KITS
• Manufacturer (Section D): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• MDR Report Key: 7330965
• MDR Text Key: 102116327
• Report Number: 9612007-2018-00002
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K040235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IP1P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR