Description of Event or Problem · 0
THE PATIENT DEVELOPED A STERNAL INFECTION. THE DOCTOR DID NOT NOTICE ANY UNUSUAL COLOR, PARTICULATES, OR OTHER UNEXPECTED ATTRIBUTE/PERFORMANCE DURING SURGERY. THE DEVICE APPEARED TO WORK AS INTENDED DURING THE SURGERY AND WAS APPLIED ONE INCH FROM THE INCISION AND PLACED ON TOP OF THE IOBAN DRAPE. THE INFECTION WAS REPORTED PRIOR TO DISCHARGE AND POD 5. A REVIEW OF HISTORIC COMPLAINTS FOUND THIS TO BE THE FIRST COMPLAINT OF THIS NATURE RECEIVED FOR THIS OR ANY OTHER NASCENT SURGICAL PRODUCT. AS OF THE DATE OF THIS MDR SUBMISSION, APPROXIMATELY 210 UNITS FROM THIS LOT HAVE BEEN DISTRIBUTED, WITH THIS BEING THE ONLY INFECTION REPORT. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE DID NOT IDENTIFY ANY MANUFACTURING RELATED NONCONFORMANCES OR CONCESSIONS TO WHICH THIS EVENT BE BE ATTRIBUTED. THE STERILIZATION BATCH RECORD WAS ALSO REVIEWED, CONFIRMING THAT ALL PARAMETERS DURING THE STERILIZATION CYCLE MET VALIDATION SPECIFICATIONS. THE DEVICE WAS DESTROYED AND THEREFORE WAS NOT AVAILABLE FOR EVALUATION. ACCORDING TO THE REPORTER, "WE ARE USING A NEW TUBING TO ADMINISTER CARDIOPLEGIA, BUT THIS TUBING IS PART OF AN EXISTING STERILE PRODUCT KIT THAT IS ALREADY ON THE STERILE FIELD." IT WAS REPORTED THAT "THE PATIENT RECOVERED NICELY AND HAS GONE HOME". THE SURGERY BEING PERFORMED WAS REPORTED TO BE A CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY, WHICH TYPICALLY INVOLVES THE USE OF MULTIPLE DEVICES AND INSTRUMENTS, AND IS KNOWN TO CARRY AN INHERENT RISK OF INFECTIOUS COMPLICATIONS. THE ROOT CAUSE FOR THE EVENT WAS NOT ABLE TO BE DEFINITIVELY DETERMINED. BASED ON THE ABOVE INFORMATION AVAILABLE AT THIS TIME AND INVESTIGATION FINDINGS, NASCENT SURGICAL DOES NOT BELIEVE THIS EVENT TO BE RELATED TO THE MICROSQUAIR DEVICE. HOWEVER, THIS REPORT IS BEING SUBMITTED CONSERVATIVELY DUE TO THE REPORT OF PATIENT INJURY. QUALITY ASSURANCE WILL CONTINUE TO MONITOR COMPLAINT REPORTS AND WILL TAKE ACTION FOR ANY FUTURE OCCURRENCES AS IS DEEMED NECESSARY.