MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CCO CATHETER INTERFACE CABLE

Model Number 70CC2

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/24/2015

Event Type  malfunction  

Manufacturer Narrative

A follow-up submission will communicate the results of the device history record review, returned product evaluation result(s), investigation and conclusion.Please see the associated mdr: 2015691-2015-02134 in reference to the vigilance monitor.

Event Description

It was reported that during use of the vigilance monitor, the cco value was abnormal - approximately 2l/min higher.However, ecg and map were as expected.No error messages were reported and the customer was not performing sv02 measurement when the atypical value was observed.There was no report of patient compromise or inappropriate treatment, and no additional system-related devices were initially identified as suspect.However, when the vigilance monitor was returned for evaluation, a 70cc2 cable was discovered attached to the monitor.While the 70cc2 cable was not implicated in the customer's report, an additional complaint was initiated to consider the cable as suspect.

Manufacturer Narrative

Review of the 70cc2 cable¿s device history record supports that there were no non-conformances noted for any reason.The cable was manufactured 01-jul-2004.As of (b)(4) 2009, extensive testing to determine the useful life of the cable was conducted and determined to be 3 years.This information was provided to edwards customers via a product notification which included recommendations for cable replacement and/or return to edwards for evaluation following the established time-period.New product labeling now includes information regarding the useful life of the product.The cable is significantly past its useful life.Examination of the returned cable was unable to find any failure of the device to perform as expected.The customer¿s complaint was unable to be confirmed as related to any failure of the cable.A cable ¿selftest¿ was executed using a vig 2 monitor.Cirris functional testing and sr720 lcr testing were all satisfactory and support that there was no failure involving the cable.No physical damage was observed and cco was run for over 10 minutes with no observed issues.See 2015691-2015-02134 for the related vigilance monitor.

• Brand Name: CCO CATHETER INTERFACE CABLE
• Type of Device: CABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5052250
• MDR Text Key: 25510665
• Report Number: 2015691-2015-02280
• Device Sequence Number: 1
• Product Code: ISN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K000664
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Health Professional
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70CC2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2015
• Is the Reporter a Health Professional?: Yes
• Device Age: 11 YR
• Date Manufacturer Received: 08/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1