CATHETER SOUNDSTAR ECO 3D DIAGNOSTIC ULTRASOUND FOR USE ON GE IMAGING SYSTEM 10F

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO 3D DIAGNOSTIC ULTRASOUND CATHETER AND THE LOCKING MECHANISM FOR THE DEFLECTION ON THE CATHETER WAS LOCKING AND GETTING STUCK IN THE LOCKED POSITION. THE DEVICE WAS RETURNED TO STERILMED FOR FURTHER EVALUATION. A NON-STERILE REPROCESSED CATHETER SOUNDSTAR ECO 3D DIAGNOSTIC ULTRASOUND FOR USE ON GE IMAGING SYSTEM 10F G WAS RECEIVED CONTAINED IN THE DECONTAMINATION BAG. UPON RECEIPT OF THE DEVICE, A VISUAL INSPECTION WAS PERFORMED AND THREE KINKS ON THE SHAFT, THE FIRST NEXT THE SERIAL NUMBER TAG, THE SECOND AT 47CM, AS WELL THE THIRD AT 50CM FROM THE STRAIN RELIEF. ALSO, A BEND WAS FOUND NEAR THE TIP. THE PHYSICAL MARK ON THE DEVICE INDICATED THAT IT HAD BEEN REPROCESSED ONE (1) TIME. THE DEFLECTION MECHANISM WAS TESTED. THE CATHETER WAS WORKING CORRECTLY, EVEN WHEN THE TIP HAS A BENT, THE CATHETER TIP ACHIEVED THE POSTERIOR (P), ANTERIOR (A), LEFT (L) AND RIGHT (R) CURVES AND MET THE SPECIFICATION. THERE WERE DIFFICULTIES WHILE MANEUVERING THE DEFLECTION LOCKING KNOB. THE CATHETER WAS THEN DISSECTED, AND NO DAMAGE WAS FOUND ON THE PULLER WIRE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE ISSUE WITH THE LOCKING MECHANISM GETTING STUCK IN THE LOCKED POSITION WAS CONFIRMED BASED ON THE FINDINGS DESCRIBED ABOVE. WITH THE LIMITED INFORMATION AVAILABLE, A CONCLUSIVE CAUSE CANNOT BE DETERMINED, HOWEVER, THE COMPLAINT WAS REPORTED TO HAVE OCCURRED INTRA-OPERATIVELY, THE DEVICE WAS ALREADY MANIPULATED BEFORE THE ISSUE WAS FOUND; FACTORS NOT DESCRIBED WITHIN THE INFORMATION AVAILABLE SUCH AS DEVICE MANIPULATION AND USE MAY HAVE CONTRIBUTED TO THE ISSUE ENCOUNTERED. THE DEFLECTION ISSUE WAS NOT CONFIRMED, AS THE TIP CONDITION ALLOWED THE DEVICE TO PERFORM THE REQUIRED CURVES AND MET THE PRODUCT SPECIFICATIONS. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. THE KINKED AND BENT CONDITIONS WERE NOT ORIGINALLY REPORTED, AND THE EXACT TIME OF OCCURRENCE CANNOT BE DETERMINED; THEREFORE, THEY ARE NOT CONSIDERED RELATED TO THE ISSUE REPORTED. AS PART OF STERILMED'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. DEVICES UNDERGO 100% INSPECTION AT DIFFERENT POINTS DURING THE MANUFACTURING PROCESS TO PREVENT DAMAGE FROM LEAVING THE FACILITY. THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. H6 CODES C19 AND D14 ARE FOR THE DEFLECTION ISSUE THAT WAS NOT CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO 3D DIAGNOSTIC ULTRASOUND CATHETER AND THE LOCKING MECHANISM FOR THE DEFLECTION ON THE CATHETER WAS LOCKING AND GETTING STUCK IN THE LOCKED POSITION. THE DOCTOR SAID IT WAS LOCKING IN THE DEFLECTED POSITION. THE CATHETER WAS REPLACED, AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

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).