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.
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-53912 & 53912A||ATAR-T2||ATAR-R X2||ATAR-MDTL|
|ATAR A||ATAR-RL||ATAR-V2||ATAR-R T4P|
|ATAR-V||ATAR MDT3||ATAR-R NP||ATAR-MDTR|
ATAR EXTENSION CABLE – DISPOSABLE MODELS:
|ATAR-53912D||ATAR D-T2||ATAR D-R X2||ATAR D-MDTL|
|ATAR D-MDT2S-V||ATAR D-R||ATAR D-MDT2||ATAR D-T|
|ATAR D-A||ATAR D-RL||ATAR D-V2||ATAR D-R T4P|
|ATAR D-V||ATAR DMDT3||ATAR D-R NP||ATAR D-MDTR|
|ATAR-D-AT||ATAR D-R1||XI. DR||XI.V|
|ATAR D-MDTS||ATAR D-R D2P||XI.MDT||XI.A|
|ATAR D-MDT||ATAR D-R T2P||XI.T|
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 [email protected].
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.