CARTO¿ 3 SYSTEM INTERFACE CABLE,34 PIN-RED TO 34 PIN-RED
Received Jun 10, 2026 · Event occurred May 11, 2026
Report 3032391-2026-00028 · MDR key 25464906
Device
Generic name
Bw Cath Cabl Thermcool 34pn Blk34pn
Manufacturer
Medline RenewalCatalog number
CR3434CTR
Lot number
CC260330
Product problems
- Communication or Transmission Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT DURING AN AFIB ABLATION THE CABLE AND CATHETER WERE CONNECTED AND THEN THE CABLE WAS CONNECTED TO THE PIU. THERE WAS NO SIGNAL ON THE CATHETER. CATHETER AND CABLE WERE UNHOOKED, PLUGGED IN WITH CORRECT ORDER A 2ND TIME AND THERE WAS STILL NO SIGNAL COMING THROUGH FROM THE CATHETER. A SECOND CABLE WAS OPENED AND THERE WAS GOOD SIGNAL ON THE CATHETER AND CASE WAS CONTINUED. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.
Description of Event or Problem
IT WAS REPORTED THAT, DURING AN AFIB ABLATION THE CABLE AND CATHETER WERE CONNECTED AND THEN THE CABLE WAS CONNECTED TO THE PIU. THERE WAS NO SIGNAL ON THE CATHETER. CATHETER AND CABLE WERE UNHOOKED, PLUGGED IN WITH CORRECT ORDER A 2ND TIME AND THERE WAS STILL NO SIGNAL COMING THROUGH FROM THE CATHETER. A SECOND CABLE WAS OPENED AND THERE WAS GOOD SIGNAL ON THE CATHETER AND CASE WAS CONTINUED.