NA
Received Jan 22, 2025 · Event occurred Dec 30, 2024
Report 2134070-2025-00001 · MDR key 21209609
Device
Generic name
Reprocessed Intravascular Ultrasound Catheter
Manufacturer
Sterilmed, Inc.Catalog number
BIO10439072
Lot number
2225440
Product problems
- Contamination /Decontamination Problem
- Contamination /Decontamination Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO CATHETER AND THE CATHETER'S TIP WAS CONTAMINATED BY A STICKER IN THE ORIGINAL PACKAGING OF THE CATHETER. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: PC-(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO CATHETER AND THE CATHETER'S TIP WAS CONTAMINATED BY A STICKER IN THE ORIGINAL PACKAGING OF THE CATHETER. WHEN THE USER REMOVED THE CATHETER FROM THE PACKAGING, A STICKER WAS STUCK TO THE TIP. WHEN THE CATHETER WAS REPLACED, THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION IN THIS COMPLAINT. HOWEVER, IT HAS NOT BEEN MADE AVAILABLE.
Additional Manufacturer Narrative
THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. 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: (B)(4).