DIAGNOSTIC EP CATH
Received Mar 7, 2024 · Event occurred Feb 12, 2024
Report 2134070-2024-00004 · MDR key 18858050
Device
Generic name
Catheter, Recording, Electrode, Reprocessed
Manufacturer
Sterilmed, Inc.Catalog number
BIOBD710FJ282CT
Lot number
2199229
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN THE DEVICE. HOWEVER, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4) H5 AND H8 WERE OMITTED ON INITIAL REPORT. THESE FIELDS HAVE BEEN UPDATED.
Additional Manufacturer Narrative
THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS, HOWEVER, A PHOTO OF THE EVENT WAS RECEIVED IN WHICH THE DISTAL END OF A CATHETER CAN BE SEEN. THE ELECTRODE #1 CAN BE SEEN SEPARATED FROM THE SHAFT OF THE CATHETER AND TIED TO THE INTERNAL WIRES. NO OTHER DAMAGES CAN BE SEEN. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE ISSUE REPORTED REGARDING THE BROKEN TIP OF THE CATHETER WAS CONFIRMED. THIS INVESTIGATION WAS PERFORMED BASED ONLY ON THE PHOTOS PROVIDED. IF THE PRODUCT IS RECEIVED AFTER THIS INVESTIGATION, AN ASSESSMENT WILL BE PERFORMED AS PER THE CONDITIONS OF THE DEVICE RETURNED. 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 DURING AN ATRIAL FIBRILLATION PROCEDURE WITH A REPROCESSED EZ STEER BI-DIRECTIONAL CS CATHETER, THE TIP BROKE WHILE ENTERING THE SHEATH. THE CATHETER DID NOT SEPARATE INTO TWO OR MORE PIECES, HOWEVER, THERE WAS WIRES/BRAID EXPOSED. THERE WAS NO PHYSICAL DAMAGE, OR ANY OTHER ISSUE OBSERVED ON THE PACKAGE OF THE DEVICE. THERE WAS NO PATIENT CONSEQUENCE.