Device product
THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
Z-0057-2018
Product summary
- Event
- Event 78129
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19 units
- Official record key
device-enforcement:Z-0057-2018
Official wording
Reason: Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.
Code information: 17688816M, 17697930M, 17697966M
Distribution pattern: US, Japan, Canada, Australia, New Zealand, Brazil, Croatia, Korea, Austria, Colombia, Italy, Portugal, Argentina, South Africa, Belgium, France, Germany, Ireland, Poland, Netherlands, Sweden, Denmark, Finland, Switzerland, Great Britain, Hungary, Czech Republic, China
Derived failure modes
-
Unknown
Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.