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 Low Readings (2460); Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Hematoma (1884); High Blood Pressure/ Hypertension (1908)

Event Type  Death  

Event Description

This report is in regards to the second device used.It was reported that the first device (mfg.Report number: 9612007-2017-00032) had a very low value; even the test was correct.The probe was used from (b)(6) 2017 on a (b)(6) female patient.Complementary information received on 30nov 2017: it was reported that the first issue with the first "fibber" was low value so they used another "fibber" which created the extra dural hematoma following insertion of ptio2 fiber responsible for intracranial hypertension.The customer hypothesized that there was an error during insertion (unintentionally in the area damaged); risky procedure due to the fact the "fibber" created some small bleeding points for no clinical advantage.The extradural hematoma was removed by surgery.Patient had severe cranial trauma complementary information received on 04dec2017: the device had low value since the beginning: - 2 am on (b)(6) value 1.3, - 11 and 12 am value 0.8, - 2 pm value 2.5, - 3 and 4 pm value 0.9, - 7 pm highest value 3.9 on (b)(6), - 12 am value 1 on (b)(6) (lowest of the day), - 10 pm value 5.9 on (b)(6) (highest of the day), - 12 am value 5.2 on (b)(6) (highest of the day), - 2 am value 1.5 on (b)(6) (lowest of the day), the device was thrown out.Linked to mfg.Report number: 9612007-2017-00032.

Manufacturer Narrative

Additional information was received on 01mar2018 from the customer with the following: a (b)(6) female was included in a study (not specified) on (b)(6) 2017 due to a serious traumatic brain injury.Initial injury assessment: bilateral periorbital ecchymosis, bilateral otorrhagia, bilateral epistaxis, haemorrhagic wound at the opposite of the occiput,+ whole body scan: right hemorrhagic contusion, right fronto-temporal traumatic arachnoid hemorrhage, left parietal extra dural hematoma, blade haemorrhagic tentacle of the cerebellum, petechiae of the brainstem and an interstitial haemorrhage.The first probe was implanted from (b)(6) 2017 to (b)(6) 2017 (mfg.Report number 9612007-2017-00032).The second probe was inserted on (b)(6) 2017 following the fact that the first one had an issue.Extradural hematoma was reported following the insertion of the second probe which "conduct" to intracranial hypertension.The hematoma and probe were removed.Intracranial pressure was under control.On (b)(6) 2017, the patient had intracranial hypertension again; decision was made for limited therapeutic and sedation.The patient died on (b)(6) 2017.As per investigator, the serious event was linked to the experimental procedure.As per sponsor of the study, the serious event was linked to the experimental procedure, insertion of the probe, and known consequence (hematoma).The sponsor did not report to the competent authority.Please note that this additional information has no impact on integra's investigation (no product was available for analysis).The issues linked to integra device were procedure related.

Manufacturer Narrative

No device was available for investigation; therefore, the complaint was deemed not confirmed.The device history record review and batch record review of the ip1p lot 0201818 did not reveal any anomalies.The batch was manufactured in may 2017 and included (b)(4) products.

• 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: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7108015
• MDR Text Key: 94512079
• Report Number: 9612007-2017-00033
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IP1P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• 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; Other; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 82