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

Model Number IP1P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Event Date 04/20/2023

Event Type  Death  

Event Description

The following event details was reported: patient was hospitalized due to severe head trauma with multiple hemorrhagic components, following to a fall down the stairs on (b)(6) 2023.It was complicated by intracranial hypertension which required the reintroduction of a neurosedation on (b)(6) 2023 (sentence to be clarified by the customer).Medical team decided to initiate neuromonitoring with ptio2 intracranial sensor in order to optimize neuroreanimation.The sensor was inserted on (b)(6) 2023.The insertion "was complicated by a subdural hematoma with intracranial hypertension during procedure (sentence to be clarified by the customer).The procedure was stopped after the passage of cranial vault due to intracranial hypertension, absence of sensor implantation, realization of emergency brain imaging.Neurosurgery was performed in emergency to evacuate the subdural hematoma after diagnosis confirmation by brain imaging.Intracranial hypertension was treated by maximal medical treatment, bilateral regressive mydriasis after surgical procedure.Recurrence of subdural hematoma during the night of (b)(6) 2023 was detected due to increase of intracranial pressure.Neurosurgeons decided to not perform other surgery.Evolution to "refractory" intracranial hypertension.The patient moved to encephalic death state.Additional information received: the insertion of the probe led to the formation of the extradural hematoma.The placement was not technically more difficult than usual.Was a causal link between the installation of the device and the patient's condition determined? the formation of the extradural hematoma resulted in intracranial hypertension.This intracranial hypertension led to the patient's death with a transition to a state of encephalic death.The causal link seems possible and probably partial (the brain was already in intracranial hypertension, hence the need for neuromonitoring).These elements will be determined during meeting and investigation.Was a malfunction of the device noticed? if so, which one? the device was not inserted.The extradural hematoma formed immediately after the bone table was passed with the drill.The insertion procedure was stopped due to the immediate rise in intracranial pressure.The device did not appear to have any particular defect.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Additional information/clarification: the hospital sent the report on the reference cc1p1; that is, the reference of the probe, but this probe was not inserted.This mdr refers to the complete kit (ref ip1p) used to insert the probe as it seems that the subdural hematoma appeared after the bone was passed with the drill included in the kit.The complete kit includes the probe cc1p1.¿ investigation findings: an evaluation of the actual pmo combined probe could not be performed because the device was not returned for investigation.Lot number was provided; therefore, device history records were reviewed which revealed no anomalies that could explain the reported event.Failure analysis & root cause - the definite root cause could not be determined as the device was not returned for investigation.However, the possible root cause for the issue reported by the customer could be due to the inadequate dimensions drill bit / bolt or design choice: incompatibility drill bit/bolt or human misuse.Additionally, the customer reported that the "device did not appear to have any particular defect." an assessment was also performed by medical safety which concludes this event as not causal to the device or related to device use.If additional information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Manufacturer Narrative

Additional information received: the probe "cc1p1" is included in the licox kit ip1p.As a result, the catalog# for this event has been updated.Update to medical assessment for this event: the device was not causal to the event or the demise of the patient.The patient succumbed to the evolution of "refractory" intracranial hypertension.

• 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
• Manufacturer (Section G): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17052808
• MDR Text Key: 316463407
• Report Number: 9612007-2023-00001
• Device Sequence Number: 1
• Product Code: GWM
• UDI-Device Identifier: 10381780250319
• UDI-Public: 10381780250319
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2023
• Device Model Number: IP1P
• Device Catalogue Number: IP1P
• Device Lot Number: 0229481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2023
• Date Device Manufactured: 05/13/2022
• 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): Death
• Patient Age: 65 YR
• Patient Sex: Female