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

Catalog Number CAMCABL

Device Problems Break (1069); Device Inoperable (1663); Improper Device Output (2953)

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

Event Type  malfunction  

Event Description

The cable was not working properly; it immediately reads above 300 on any machine.There was no physical damage on the cable.The cable was identified as providing unreliable icp numbers.The sales representative went and tested the cable with 3 monitors in the picu with a 1104b bolt.When used with every machine, it provided an icp number at or above 300.Using the same 1104b with a different camcabl on all 3 machines provided a "zeroed" number.There are no marks on the cable and it looked brand new.There was no patient contact, no patient injury, no patient prepped for surgery, and no delay in surgery.

Manufacturer Narrative

Integra has completed their internal investigation on 03/25/2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: during investigation, it was observed that the camcabl cable read high or no icp values when the cable was flexed at the catheter casing side due to internal wire connection failure.When the insulation was removed at the weak point, the white cable strand was shown to have a kink or a strain.All other wires at this location were in good condition.The dhr review has been deemed satisfactory.A minimum of 12 month review of camcabl cable customer complaints was completed using the following key words ¿pressure display issue¿ and a root cause ¿connection failure¿ in search criteria.This review encompassed from dates 20-jan-2015 to 10-mar-2016.A total of 20 complaints were reviewed of which 3 complaints contained the search criteria.The analysis of the complaint investigations and root cause reports has concluded this complaint is the 1st identified complaint for the reported failure associated with the camcabl cable due to internal wire connection failure.No trend has been identified.The failure analysis investigation has concluded the cause of the camcabl cable not working was due to white cable strand shown to have a kink or a strain resulting in cable reading high or no icp values; thus internal wire connection failure.This damage / fault to the cable can be potentially caused during production of the raw cable material by the supplier or during manufacturing of the camcabl cable in integra (b)(4).However, since only a single wire internal connection was twisted and no visual damage / twisting was observed to other wires or the external catheter casing to cable connection it can be concluded that this fault is related to the supplier.

• 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: 5414369
• MDR Text Key: 38252565
• Report Number: 3006697299-2016-00085
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: CAMCABL
• Device Lot Number: TL-324372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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