NEFF PERCUTANEOUS ACCESS SET

Additional Manufacturer Narrative

. G4 - PMA/510(K) #: EXEMPT H3 - DEVICE EVALUATED BY MFG? DEVICE EVALUATION ANTICIPATED BUT HAS NOT YET BEGUN. AWAITING DEVICE RETURN. 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 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 THE NEFF PERCUTANEOUS ACCESS SET WAS FOUND TO BE UNRAVELED UPON OPENING THE PACKAGE DURING A RIGHT-SIDE GALLBLADDER PUNCTURE FOR A 54-YEAR-OLD FEMALE PATIENT. THE COMPLAINT DEVICE WAS UNABLE TO BE USED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.