INTENDED USE: The extension cable is intended to connect an electrode/lead from a patient or another cable to a diagnostic machine or an external pacemaker.

DEVICE DESCRIPTION: The ATAR cable is an extension cable with connector(s) on both sides, designed to connect with various receptacles or cables/leads, depending on the instrument being used.

REASON FOR THE VOLUNTARY PRODUCT REMOVAL:

During the use of some ATAR extension cables, the cable was separating from the connector at the proximal end. The analysis of the returned devices revealed a change in the manufacturing sequence attributed to the connector and wire separation, causing a fracture of the conductor cable from extensive use.  This event resulted in cable malfunction, causing interruption of the pacing system.  Oscor received a total of 66 complaints related to that failure mode, of which 5 resulted in patient injuries.  No deaths were reported; however the risk for possible injury is a concern if the cable separates during use.    WARNING:

For pacing dependent patients, an interruption of pacing system could result in serious injury or death if not detected. Continuous monitoring is required.

ATAR EXTENSION CABLE – REUSABLE MODELS:

 ATAR EXTENSION CABLE - DISPOSABLE MODELS:

Customer may contact Oscor’s Customer Service Group, Monday to Friday from 8:30AM to 6:00PM Eastern Time at 727-937-2511 or via email at atar@oscor.com.

Healthcare professionals are encouraged to report any malfunction and/or adverse events related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm Download form or call 1-800-332-1088 to request a reporting form, then complete and return to    the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.  

###