NA
Received Apr 16, 2026 · Event occurred Mar 26, 2026
Report 2134070-2026-00008 · MDR key 24905987
Device
Generic name
Catheter, Recording, Electrode, Reprocessed
Manufacturer
Sterilmed, Inc.Catalog number
BIOBD710DF282CT
Lot number
2245339
Product problems
- Contamination /Decontamination Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A REPROCESSED EZ STEER BI-DIRECTIONAL CS DEFLECTABLE CATHETER AND WHEN THE STERILMED CATHETER PACKAGING WAS OPENED THERE WAS A WHITE RESIDUE ON THE CATHETER. THE CATHETER WAS REPLACED WITH ANOTHER AND THE CASE CONTINUED. THE STERILE PACKAGING WAS NOT OPENED UNTIL THE TIME OF THE PROCEDURE. THERE WAS NO PHYSICAL DAMAGE OR ANY OTHER ISSUE OBSERVED ON THE PACKAGE OF THE DEVICE. NO PATIENT CONSEQUENCE WAS REPORTED.
Additional Manufacturer Narrative
THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY STERILMED INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, STERILMED INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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: PC-(B)(4).
Additional Manufacturer Narrative
CORRECTION TO D4. PRIMARY UDI NUMBER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).