MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-02 for CCO CATHETER INTERFACE CABLE 70CC2 manufactured by Edwards Lifesciences.
[25510665]
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
Patient Sequence No: 1, Text Type: N, H10
[25510666]
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.
Patient Sequence No: 1, Text Type: D, B5
[33273149]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2015-02280 |
| MDR Report Key | 5052250 |
| Date Received | 2015-09-02 |
| Date of Report | 2015-07-27 |
| Date of Event | 2015-07-24 |
| Date Mfgr Received | 2015-08-27 |
| Device Manufacturer Date | 2004-07-01 |
| Date Added to Maude | 2015-09-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LYNN SELAWSKI |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9497564386 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CCO CATHETER INTERFACE CABLE |
| Generic Name | CABLE |
| Product Code | ISN |
| Date Received | 2015-09-02 |
| Returned To Mfg | 2015-09-29 |
| Model Number | 70CC2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 11 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-02 |