MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER; LICOX BOLTS CATHETERS & KITS

Catalog Number IP2P

Device Problem Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident will not be returned for evaluation since it had been discarded by the customer.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A regulatory affairs associate reported on behalf of the customer that an ip2p probe kit was used on (b)(6) 2018 and the values in the lcx02 monitor fluctuated quickly between 21 and 23.Additional follow-up information was received on (b)(6) 2018 stating that the ip2p catheter was inserted on a (b)(6) year old male patient and when looking at the licox value on the monitor, one of the staff members noticed that the numbers were toggling oddly between 2 to 3 values.After the product issue occurred, the equipment was used as if there was no issue.The customer did not believe that there was any patient injury.Since the catheter had been discarded, the customer was not certain of the catheter lot or serial number; could possibly be lot number 0203216 with serial number (b)(4) or lot number 0202186 with serial number (b)(4).

Manufacturer Narrative

Additional information was received on 21jun2018 indicating that after probe insertion, the abnormal fluctuations were noted up until it was removed approximately 6-7 days.It was always abnormally fluctuating but did slow down after 24 hours and got little better everyday.Few computed tomography of head was done after to verify the probe location.The neurosurgeon confirmed that it is in the white matter however, there was an axial hematoma just above it.The device was not returned to the manufacturer for physical evaluation.The event reported oxygen pressure values in the licox system fluctuated quickly between 21 and 23 mmhg, when used with a licox probe ref ip2p.No traceability information was initially available; the probe was discarded.From the hospital, ref ip2p probe could be either from lot # 0203216 (sn (b)(4)) or from lot # 0202186 (sn (b)(4)).Each probe is tested within specifications at time of manufacturing and probes from both lots were tested within specifications at time of manufacturing, as shown on the device history records.The probe is not available for investigation, therefore complaint reported cannot be verified, and with the additional information confirming correct probe placement and sufficient time to allow probe stabilization, the exact cause of the reported rapid fluctuations could not be determined.

• Brand Name: KIT CONTAINING CC1.P1 AND THE IP2 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: 7628606
• MDR Text Key: 111991847
• Report Number: 9612007-2018-00014
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: 040235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IP2P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LCX02 MONITOR; LCX02 MONITOR
• Patient Age: 26 YR