MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES CA/USA INTRACRANIAL PRESSURE / TEMPERATURE MONITORING K; N/A

Catalog Number 1104BT

Device Problems No Device Output (1435); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2015

Event Type  Injury  

Event Description

After having monitoring for one day, it was noted that there was no intracranial pressure (icp) recognition and the display didn't show any information.Therefore, the catheter was changed for another 110-4bt which worked fine reporting the icp.Additional information was received from the distributor on 09 sep 2015 with the following: on (b)(6) 2015, the catheter was implanted on a (b)(6) male patient with an underlying medical condition of intracranial hypertension for trepanation and monitoring of icp and temperature.There was no harm reported.However, on (b)(6) 2015, the catheter was removed and replaced.

Manufacturer Narrative

Integra has completed their internal investigation on 11/10/2015.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: visually inspection revealed that the catheter was used and bent at approximately 5cm and 7.5cm from the catheter distal end.Microscopic inspection discovered that reference and signal fibers were damaged at the 5th marked teflon tubing.The customer reported serial number (b)(4).The customer stated that they used the replacement catheter lot 305000323654 and it worked fine.The tw reported catheter serial number (b)(4), and the lot number 305000323654.The reported catheter (b)(4) is belonged to model 110-4bt lot 30500x324564 mfg on 20 feb 2015, and will be expired on 31 dec 2017.The catheter met requirements before released to finished goods.Complaint history, model 110-4xxx, from oct-2014 through sep-2015 reviewed; there were (b)(4) other complaints that issued with complaint code perf023, and eight of them were confirmed; a failure rate percentage (b)(4).Conclusion: the reported customer complaint that the catheter exhibited ¿no icp recognition and the display didn¿t show any information¿ was verified.The reported complaint appears to be the result of inappropriate use of the device by the end user.This conclusion is based on the catheter appearance.The catheter sustained an excessive bend towards the catheter distal end and optical fiber damage was found at this bend location.The dfu included with each camino catheter monitoring kit cautions the user ¿extreme bending and/or kinks can impair the performance of the fiber optic pressure transducer¿ and to ¿exercise caution when handling the catheter¿.

• Brand Name: INTRACRANIAL PRESSURE / TEMPERATURE MONITORING K
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES CA/USA; 5955 pacific center boulevard; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer (Section G): INTEGRA NEUROSCIENCES CA/USA; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5075071
• MDR Text Key: 25697552
• Report Number: 2023988-2015-00030
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K102875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/21/2015

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: 1104BT
• Device Lot Number: 305000323654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/21/2015
• Initial Date FDA Received: 09/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2015
• 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): Required Intervention
• Patient Age: 19 YR