MAUDE Adverse Event Report: GMS COMPLETE BRAIN IMC-PROBE KIT: CC1.SB PROBE IM1 SINGLE LUMEN BOLT STERILE; LICOX BOLTS CATHETERS & KITS

Catalog Number IM1S

Device Problems False Reading From Device Non-Compliance (1228); No Device Output (1435)

Patient Problems Death (1802); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

Information from linked mfg report number: 9617494-2015-00029 (first licox probe).It was reported that the probe was working perfectly until it was disconnected during a medical examination of the patient.When reconnecting the probe on the same monitor with the same card, the value reading was zero for ptio2 (brain tissue oxygenation pressure).They had to use another probe.Date of the event was on (b)(6) 2015.There was no patient injury.It was unknown if the event lead to an increase in surgery time.Additional information received on 17dec2015 and 18dec2015 with the following: date of the event: (b)(6) 2015.The licox was implanted on (b)(6) 2015 at 16h30.The patient was coming back from the scanner and the licox probe (lot 010615 serial (b)(4)) was reconnected to the monitor (lot 1210002).The value read zero.The monitor was replaced by another monitor with the same lot 12100002.This change did not permit to read the value.It was reported that there was no monitoring during several hours.Another licox probe was implanted during the night of (b)(6) 2015 to (b)(6) 2015.The new licox probe (lot 260515 serial (b)(4)) was connected to the monitor lot 1210002 (second one test previously) and the value of ptio2 read correctly until they planned to take off the probe on (b)(6) 2015.Just before the planned "ablation" of the licox probe, the monitor had been disconnected several times at the level of the monitor and even with the disconnection and reconnection done, the value of ptio2 still read.When they disconnected at the level of the licox probe and reconnected after, there was no value.The physicians have decided to implement a temporary corrective action which was to disconnect the licox at the monitor connection level even though there was more risk to damage the licox probe due to the fact that the patient is being moved with the licox probe and cable still connected.Note: it was reported that 3 patients were involved with same issue on the licox.The hospital has identified more clearly that they used to disconnect the licox for medical examination at the catheter level and when they would reconnect, it would then not work.There would be no value when reconnecting.They tried to disconnect at the licox at the monitor level when performing medical examination (patient with the catheter and cable).When they reconnect it, it was working.Patients were reported to be woman and men between the ages of 18 to 50 years old.Reason for the use of the licox was for cranial trauma.The card was normally taken off.On the 3 patients involved, outcomes were reported as 1 death and 2 normal courses for cranial trauma.It was not reported and specified which one of the 3 patients died.Other linked mfg report numbers: 9617494-2015-00032, 9617494-2015-00033.

Manufacturer Narrative

Integra has completed their internal investigation on 05feb2016.The investigation included: methods: evaluation of actual device review of device history records.Review of complaint history.Results: evaluation of device: an optical investigation of the cc1.Sb showed that the tip (nose) of the catheter was cut off (clean cut).Due to this cut the catheter tip is open what leads to a leak of electrolyte solution.Furthermore air, blood and other material found their way inside the catheter tube through that cut.Additionally both catheter wires were wavy what indicates that tensile force must have been applied to the catheter.The optical investigation of the im1 introducer showed that the tip of the introducer was also cut off to a length 26mm where 43 -1mm is the specification.The cc1.Sb was evaluated by conducting a performance test in water at 36.92 °c bath temperature, 20.9% oxygenation and 753.3 mmhg barometric pressure.The test device showed a po2 value of 32.23 mmhg whereby the nominal value was 147.65 mmhg.The oxygen measurement performance of the cc1.Sb is out of specification.During the performance test the po2 value was jumping between no readings and the value mentioned above.This behavior became worse by slightly rotating the catheter housing.Due to the fact that sometimes ¿no readings¿ were shown an electrical test of the connections was conducted.This test showed a possible break of the anode wire somewhere between the tip of the catheter and the connector.A stepwise dismounting of the catheter showed that the anode wire was broken inside the connector housing.Furthermore the lemo pin inside the connector housing was loose what indicates that the pin must have been rotated somehow.No anomalities have been reported.No ncr or any variances were associated with this lot.The lot met the specification at the time of release.No trend could be determined.In summary the cc1.Sb had leak of electrolyte solution through a clean cut of the catheter tube tip (nose).Additionally the wires were wavy what indicates that tensile force must have been applied to the catheter.Furthermore the lemo pin connector inside the connector housing was loose.A functional test and dismounting the catheter showed a broken anode wire.The im1 introducer system had a damaged introducer tip caused by a clean cut at 26mm length.

• Brand Name: COMPLETE BRAIN IMC-PROBE KIT: CC1.SB PROBE IM1 SINGLE LUMEN BOLT STERILE
• Type of Device: LICOX BOLTS CATHETERS & KITS
• Manufacturer (Section D): GMS; dorfstrasse 2a; dorfstrasse 2a; mielkendorf D2247 ; GM D2247
• Manufacturer (Section G): GMS; dorfstrasse 2a; mielkendorf D2247 ; GM D2247
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5324891
• MDR Text Key: 34323562
• Report Number: 9617494-2015-00031
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K002765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup
• Report Date: 12/18/2015

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 Catalogue Number: IM1S
• Device Lot Number: 260515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2015
• 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): Other