N/A
Received May 28, 2026 · Event occurred May 5, 2026
Report 2134070-2026-00013 · MDR key 25325265
Device
Generic name
Reprocessed Intravascular Ultrasound Catheter
Manufacturer
Sterilmed, Inc.Catalog number
R10439236
Lot number
2252056
Product problems
- Tear, Rip or Hole in Device Packaging
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
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).
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER AND THE PATIENT WAS PREPPED IN THE CENTERS USUAL FASHION FOR A PVI CASE. UPON OPENING THE PACKAGING FOR THE SOUNDSTAR CATHETER, IT WAS NOTICED THAT THE SEAL ON THE PACKAGE HAD ALREADY BEEN PARTIALLY OPENED. DUE TO STERILITY PROTOCOL, THE SOUDSTAR CATHETER WAS NOT USED, AND IT WAS EXCHANGED FOR A NEW ONE. THERE WAS NO PHYSICAL DAMAGE OR ANY OTHER ISSUE OBSERVED ON THE PACKAGE OF THE DEVICE. THE PRIMARY PACKAGING BOX WAS NOT OPENED BEFORE THE SURGERY. THERE WAS NO SIGNIFICANT DELAY OR PATIENT HARM.