MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES CA/USA SUBDURAL POST CRANIOTOMY ICP MONITORING KIT; N/A

Catalog Number 1104G

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 11/04/2015

Event Type  malfunction  

Event Description

A (b)(6) year old male patient underwent an "outside decompression".The 1104g catheter was zeroed prior to insertion and was implanted on (b)(6) 2015.It had worked correctly.On (b)(6) 2015, the catheter was removed from the pac-1 cable and the patient was in transit.After that, there was no output from the catheter; no pressure value was shown after reconnecting the catheter to the pac-1 cable.The hospital staff checked the connection; disconnected and connected it to the cable but the problem was not fixed.There was no patient injury.The catheter was explanted then.There was no replacement catheter.There was no surgery delay.Patient outcome was reported as "no change".Additional information has been requested.

Manufacturer Narrative

Additional information received on 15dec2015: the patient was monitored without any catheters after the incident and determined no replacement is needed in view of the risk of the re-surgery.

Manufacturer Narrative

Integra has completed their internal investigation on (b)(4) 2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: the catheter had excessive bends and damaged fibers were present at one of the bent location.A review of batch history record indicates that lot 305000327114 met all requirements before released to finished goods.Complaint history, model 110-4xxx, from dec-2014 through nov-2015 reviewed; there were (b)(4) other complaints that issued with complaint code perf023, and (b)(4) of them were confirmed.The number of units, model 110-4xxx (37609) dec-2014 through nov-2015 divided by the number of confirmed reports (b)(4) and multiplied by 100 results in a failure rate percentage (b)(4).The reported customer complaint that the catheter was not functional was verified.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 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: SUBDURAL POST CRANIOTOMY ICP 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: 5286289
• MDR Text Key: 33849093
• Report Number: 2023988-2015-00048
• 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,Followup
• Report Date: 11/20/2015

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 Expiration Date: 03/28/2018
• Device Catalogue Number: 1104G
• Device Lot Number: 305000327114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/10/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/15/2015; 03/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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 Age: 72 YR