MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR; ICP MONITORING

Catalog Number CAM02

Device Problems No Device Output (1435); Improper Flow or Infusion (2954)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The cam02 inter-cranial pressure and temperature monitor experienced a catheter failure.The date of the incident was not provided.The device was not in contact with the patient and there was no injury, no death alleged, no revision or medical intervention and the patient was not prepped for surgery.It was unknown if there was a delay in surgery due to the product problem.Additional information has been requested.

Manufacturer Narrative

Investigation completed on 11/30/2016.-device history review, -trend analysis, -failure analysis.The device history review verified no anomalies that could be associated with the reported complaint.All the functionality tests were carried out accordingly and all results of the tests were recorded as within specification prior to the cam02 monitor been released.Trending analysis: a review of the customer complaints was competed using the following key words ¿catheter failure¿ and a root cause ¿icp flex cable¿ in the search criteria.The review encompassed dates 20-oct-2015 to 29-nov-2016.This is the only complaint occurrence which contained the search criteria.(b)(4).The failure analysis evaluation verified the complaint as valid.The service centre verified the catheter failure occurred due to a defective icp flex cable assembly.The cam02 monitor received a replacement icp flex cable assembly, was calibrated and safety tested.The results were reviewed as part of this evaluation, all the functionality tests were carried out accordingly and all results of the tests were recorded as within specification.The evaluation verified the complaint as valid; the cause of the complaint issue was identified as a defective icp flex cable assembly.Based on the complaint investigation completed it can be concluded no further evaluation is required.Future complaints will be continued to be monitored and trended.Conclusion: the evaluation verified the complaint as valid; the cause of the complaint issue was identified as a defective icp flex cable assembly which resulted in a catheter failure.

• Brand Name: INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR
• Type of Device: ICP MONITORING
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6090894
• MDR Text Key: 60027233
• Report Number: 3006697299-2016-00201
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K121573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2016

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: CAM02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/17/2016
• Initial Date FDA Received: 11/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1