MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) FIBRE OPTIC CATHETER CABLE; ICP MONITORING

Catalog Number CAMCABL

Device Problems Defective Device (2588); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The monitor was detecting catheter failure.They switch it out with a couple of catheters, same issue.The customer did not have another cable to determine if the cable was the cause for the failure.It was unknown if the device was being used on the patient or if there was any patient injury or delay.Additional information has been requested.Linked to mfg.Report number: 3006697299-2017-00105.

Manufacturer Narrative

Investigation completed 07/27/2017.A minimum of 12 months¿ review of camcabl cable customer complaints was completed for the reported failure using the following key words ¿functionally defective cable ¿ intermittent icp readings ¿ root cause not determined¿ in the search criteria.The key word search review contained all and/or part of the key words to complete a comprehensive trend review.This review encompassed dates 26-jul-2016 to 26-jul-2017.6 complaints contained the search criteria.Rate of occurrence: during the time period ¿aug-16 to jul-17¿, the global product usage for camcabl was calculated as 39,480 usages, using the total quantity of icp monitors¿ catheters sold to calculate the quantity of usages.The quantity of 6 x complaints over the 12-month period with the key words identified in the complaint review can therefore be calculated as (b)(4) of procedures.Reported failure was confirmed; during investigation it was observed that the returned camcabl cable had an intermittent icp readings, however, the root cause of the intermittent failure was not determined.The faulty camcabl cable was returned to the customer labelled as reject.Replacement camcabl cable serial number (b)(4) was sent to customer with the returned cam02 monitor.Root cause not determined; cable had intermittent icp readings, however, the root cause of the intermittent failure was not determined by service centre.

• Brand Name: FIBRE OPTIC CATHETER CABLE
• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6676470
• MDR Text Key: 78835557
• Report Number: 3006697299-2017-00104
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CAMCABL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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