N/A
Received Jun 25, 2026 · Event occurred May 26, 2026
Report 2134070-2026-00018 · MDR key 25630452
Device
Generic name
Reprocessed Intravascular Ultrasound Catheter
Manufacturer
Sterilmed, Inc.Catalog number
R10439236
Lot number
2253732
Product problems
- Tear, Rip or Hole in Device Packaging
- Material Twisted/Bent
- Packaging Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR 8F CATHETER AND THE CATHETER WAS PHYSICALLY BENT AT THE TIP TO SHAFT TRANSITION. IN ADDITION, THERE WAS DAMAGE TO THE BOX AND POUCH, IN WHICH THE STERILITY WAS COMPROMISED. NOTHING WAS OPENED PRIOR TO USE, WHEN PREPPING THE DEVICE FOR SURGERY IS WHEN IT WAS OPENED.
Additional Manufacturer Narrative
THE PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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).