EP DIAGNOSTIC CATHETER LIVEWIRE DECA EXTRA LARGE CURL

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION PROCEDURE WITH A REPROCESSED EP DIAGNOSTIC CATHETER LIVEWIRE DECA EXTRA LARGE CURL AND THERE WAS A SEPARATION WHERE THE LAST ELECTRODE CONNECTS TO THE SHAFT OF THE CATHETER WITH INTERNAL COMPONENTS EXPOSED. MULTIPLE ATTEMPTS HAVE BEEN COMPLETED TO OBTAIN PRODUCT RETURN STATUS OR TRACKING INFORMATION, TO NO AVAIL. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THIS TIME. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

Additional Manufacturer Narrative

THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REF. NO: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION PROCEDURE WITH A REPROCESSED EP DIAGNOSTIC CATHETER LIVEWIRE DECA EXTRA LARGE CURL AND THERE WAS A SEPARATION WHERE THE LAST ELECTRODE CONNECTS TO THE SHAFT OF THE CATHETER WITH INTERNAL COMPONENTS EXPOSED. THE PACKAGE WAS OPENED AT THE TIME THE PHYSICIAN REQUESTED THE DEVICE FOR USED, HOWEVER, IT IS UNKNOWN IF THERE WAS ANY PHYSICAL DAMAGE TO THE PACKAGING. THERE WAS NO PATIENT CONSEQUENCE.