SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER
Received May 30, 2024 · Event occurred May 13, 2024
Report 2134070-2024-00012 · MDR key 19426538
Device
Generic name
Catheter, Electrode Recording
Manufacturer
Sterilmed, Inc.Catalog number
R10439011
Lot number
2205705
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
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).
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR® ECO 8F DIAGNOSTIC ULTRASOUND CATHETER AND FOREIGN MATERIAL WAS FOUND ON THE CATHETER AFTER OPENING THE STERILE PACKAGING. THE MATERIAL LOOKED LIKE ADHESIVE TAPE. THE CATHETER WAS EXCHANGED, AND THE ISSUE WAS RESOLVED. THE CASE CONTINUED. THERE WAS NO REPORTED PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION IN THIS COMPLAINT. HOWEVER, IT HAS NOT BEEN MADE AVAILABLE.
Additional Manufacturer Narrative
CONCOMITANT PRODUCTS WERE OMITTED IN ERROR FROM INITIAL REPORT. PLEASE SEE SECTION D10. 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
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. THEREFORE, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO NON-CONFORMANCE'S RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).