SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE WITH A SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER AND A FOREIGN MATTER INSIDE THE PACKAGING ISSUE OCCURRED. THE DEVICE EVALUATION WAS COMPLETED ON 19-JUL-2023. THE DEVICE WAS RETURNED TO STERILMED FOR EVALUATION. A NON-STERILE REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER WAS RECEIVED IN ITS ORIGINAL SEALED POUCH. VISUAL INSPECTION WAS PERFORMED, AND BLACK PARTICLES WERE OBSERVED ADHERED TO THE POUCH AND ALONG THE LENGTH OF THE CATHETER. THE PHYSICAL MARK ON THE CATHETER INDICATED THAT IT HAD BEEN REPROCESSED ONE (1) TIME. THE PARTICLES WERE SUBMITTED TO FOURIER TRANSFORMED INFRARED SPECTROSCOPY (FT-IR) ANALYSIS, AND IT WAS CONCLUDED THAT THE FOREIGN MATERIAL IS PRIMARILY COMPOSED OF A BIOLOGICAL-BASE MATERIAL. THE DEVICE HISTORY RECORDS (DHR) FOR LOT NUMBER 2176602 WERE REVIEWED AND NO EVIDENCE OF DEFICIENCIES RELATED TO THE REPORTED COMPLAINT WAS FOUND DURING THE MANUFACTURING PROCESS. NO INTERNAL ACTIONS WERE GENERATED DURING THE MANUFACTURING PROCESS. COMPLAINT HISTORY FOR PRODUCT CODE R10439011 (SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER), FOUND NO SIMILAR EVENTS REPORTED. THE REPORTED EVENT WAS CONFIRMED BASED ON THE APPEARANCE OF THE RETURNED DEVICE. THE FT-IR RESULTS AND THE CONFIRMED CONDITION OBSERVED ON THE RETURNED DEVICE SUGGEST THAT THE ISSUE OCCURRED AFTER THE FINAL INTENDED POINT OF DETECTION. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE THIS ISSUE. AS PART OF STERILMED¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS ISSUE IS BEING ADDRESSED THROUGH STERILMED¿S QUALITY SYSTEM. H6. COMPONENT CODE OF ¿APPROPRIATE TERM/CODE NOT AVAILABLE¿ REPRESENTS FOREIGN MATTER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE WITH A SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER AND A FOREIGN MATTER INSIDE THE PACKAGING ISSUE OCCURRED. INSIDE THE STERILE PACKAGING OF THE REPROCESSED CATHETER, IT HAD SOME BLACK SPECKS OF A FOREIGN SUBSTANCE. THEY COULD SEE IT THROUGH THE PACKAGING SO THEY DECIDED NOT TO OPEN IT. THE CATHETER WAS REPLACED WITH ANOTHER REPROCESSED CATHETER AND THE ISSUE WAS RESOLVED. THIS IS THE ONLY CATHETER THAT THEY FOUND TO HAVE THIS ISSUE IN THE ACCOUNT INVENTORY. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE CATHETER WITH THE LOT NUMBER OF 2176602 HAD THE FOREIGN SUBSTANCE IN STERILE PACKAGE ISSUE. THE BOX WAS OPENED, BUT NOT THE STERILE PACKAGING. THERE WAS NO PHYSICAL DAMAGE OR ANY OTHER ISSUE OBSERVED ON THE PACKAGE OF THE DEVICE WITH THE FOREIGN SUBSTANCE (OUTER BOX, TRAY, POUCH). THE FOREIGN SUBSTANCE WAS LOOSE IN THE PACKAGE, NOT ON THE DEVICE. PICTURES ARE NOT AVAILABLE, BUT PACKAGE WAS UNOPENED. THE CATHETER WAS LEFT IN THE STERILE PACKAGING. THE OUTER BOX IS NOT AVAILABLE. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR FOREIGN MATTER INSIDE THE PACKAGING ISSUE.

Additional Manufacturer Narrative

THE STERILMED PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 22-MAR-2023. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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).