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

Catalog Number 1104B

Device Problems No Display/Image (1183); No Device Output (1435); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2015

Event Type  malfunction  

Event Description

It was reported that the catheter showed normal reading for about 4 hours after the insertion and then after four hours, the readings went to blank and the icp monitor only showed the integra logo on it.Additional information was requested and on 18dec2015, the following was received: on (b)(6) 2015, the catheter was implanted on a (b)(6) male patient for a "tight brain stem".The procedure was performed by a resident neurosurgeon.The catheter was zeroed to atmosphere by using zeroing tool provided prior to implantation.The patient was not moved at any point immediately before the issue was discovered.The cable was clipped to the sheets.Troubleshooting measures included changing the pre-amp cable and icp monitor but nothing happened; there was still no icp reading for 4 to 5 hours.The device was not replaced with another catheter.An external ventricular drain (evd) was used for icp monitoring.There was no adverse patient consequences due to the icp reading not being available for 4 to 5 hours.

Manufacturer Narrative

Integra has completed their internal investigation on 03/01/2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: the catheter was returned and it was secured in the introducer assembly.Foreign object matters that appear to be dried blood was found on the catheter, on/in the introducer assembly.Tape adhesive residues was present on the catheter body.When the catheter was connected to test monitor 420-6, the monitor displayed 888-15 indicating that the monitor did not recognize the catheter.The introducer was removed and found excessive bend adjacent to the 6th marked teflon tubing, and one reference fiber was found to have been damaged at the bent location.A review of batch history record indicates that lot met requirements before released to finished goods.Product exp.Date: 2016-12.(b)(4).The reported customer complaint that the catheter stopped functioning was confirmed.The root cause of 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 excessive bends towards the catheter distal end and optical fiber damage was found at the 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: OLM INTRACRANIAL PRESSURE MONITORING KIT
• 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; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5316348
• MDR Text Key: 34767779
• Report Number: 2023988-2015-00051
• 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,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1104B
• Device Lot Number: 305000295382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2014
• 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 Age: 23 YR