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-53912 & 53912A | ATAR-T2 | ATAR-R X2 | ATAR-MDTL |
| ATAR-MDT2S-V | ATAR-R | ATAR-MDT2 | ATAR-T |
| ATAR A | ATAR-RL | ATAR-V2 | ATAR-R T4P |
| ATAR-V | ATAR MDT3 | ATAR-R NP | ATAR-MDTR |
| ATAR-AT | ATAR-R1 | XI.DR | XI.DV |
| ATAR-MDTS | ATAR-R D2P | XI.DMDT | XI.DA |
| ATAR-MDT | ATAR-R T2P | XI.DT |
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.
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