FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

Additional Manufacturer Narrative

E1: PHONE NUMBER: (B)(6). G4: PMA/510(K) #: PREAMENDMENT. H3: DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. 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 PRIOR TO A URETER PROCEDURE, UPON OPENING THE PACKAGE, A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET'S STENT WAS FOUND BROKEN NEAR THE END OF THE PIGTAIL. THE STENT WAS REPLACED WITH A NEW SAME-LIKE DEVICE TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.