MAUDE Adverse Event Report: NATUS NEURO INCORPORATED CAMINO ICP; INTRACRANIAL PRESSURE / TEMPERATURE MONITORING KIT

Model Number 1104BT

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/07/2019

Event Type  Injury  

Manufacturer Narrative

Reference (b)(4).Customer confirmed product is not available for return for additional evaluation.Customer indicates product was inserted without incident on (b)(6) 2019.Product was then removed without incident on (b)(6) 2019.On (b)(6) 2019, during cerebral ct scan, user found presence of a 3mm metallic foreign body.

Event Description

Catheter detached during procedure, leaving a part behind in the patient.

• Brand Name: CAMINO ICP
• Type of Device: INTRACRANIAL PRESSURE / TEMPERATURE MONITORING KIT
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer (Section G): NATUS NEUROLOGY INCORPORATED; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer Contact: janessa boone ; 3150 pleasant view road; middleton, WI 53562 ; 6088298603
• MDR Report Key: 9355047
• MDR Text Key: 167408348
• Report Number: 3010611950-2019-00066
• Device Sequence Number: 1
• Product Code: GWM
• UDI-Device Identifier: 10381780023630
• UDI-Public: 10381780023630
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K962928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1104BT
• Device Catalogue Number: 1104BT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 35 YR