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U.S. Department of Health and Human Services

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

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INTEGRA NEUROSCIENCES CA/USA OLM INTRACRANIAL PRESSURE MONITORING KIT; N/A Back to Search Results
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¿.
 
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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 Key5316348
MDR Text Key34767779
Report Number2023988-2015-00051
Device Sequence Number1
Product Code GWM
Combination Product (y/n)N
PMA/PMN Number
K102875
Number of Events Reported1
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 Number1104B
Device Lot Number305000295382
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/02/2015
Initial Date FDA Received12/21/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/11/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age23 YR
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