WAYNE PNEUMOTHORAX TRAY

Additional Manufacturer Narrative

G4 ¿ PMA/510(K) #: EXEMPT. H3 ¿ THE DEVICE IS NOT BEING RETURNED FOR EVALUATION. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

IT WAS REPORTED THAT THE WIRE GUIDE INCLUDED IN A WAYNE PNEUMOTHORAX TRAY WAS DIFFICULT TO REMOVE AND UNRAVELED. THE WAYNE CHEST TUBE WAS THREADED OVER THE WIRE AS PER THE USUAL. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE WIRE AND OBTURATOR WITH A NORMAL AMOUNT OF FORCE, THE WIRE "STRETCHED". MANY ATTEMPTS WERE MADE TO RELEASE THE WIRE WITH NO SUCCESS. THEY ULTIMATELY REMOVED ALL DEVICE COMPONENTS TOGETHER. A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. NO UNINTENDED PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT. A CUSTOMER PROVIDED PHOTO REVEALS AN UNRAVELED WIRE GUIDE. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.