N/A

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT SIDED IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION WITH A REPROCESSED SOUNDSTAR CATHETER AND THE PATIENT EXPERIENCED CARDIAC PERFORATION/PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS. AFTER CREATING A CARTOSOUND MAP THEN MAPPING THE RV (RIGHT VENTRICLE) WITH THE QDOT CATHETER, THE PHYSICIAN NOTED THAT THE STERILMED SOUNDSTAR DID NOT LOOK LIKE IT WAS IN THE CORRECT PLACE, POSSIBLY PERFORATING THE RV. A PERICARDIAL EFFUSION WAS VISUALIZED USING THE STERILMED SOUNDSTAR CATHETER. A PERICARDIOCENTESIS WAS PERFORMED REMOVING 250 ML OF FLUID. THE PATIENT WAS STABLE. THE PROCEDURE WAS NOT COMPLETED. NO RF (RADIOFREQUENCY) OR TRANSSEPTAL WAS PERFORMED PRIOR TO THE EFFUSION. THE STERILMED DEVICE FUNCTIONED AS EXPECTED. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS INTRACARDIAC ECHOCARDIOGRAM CATHETER (SOUNDSTAR) PERFORATION OF THE RV.

Additional Manufacturer Narrative

D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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).