FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. A6 - RACE: YELLOW 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 THE STENT OF A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET BROKE PRIOR TO USE DURING A TRANSURETHRAL URETEROSCOPIC STONE FRAGMENTATION AND REMOVAL PROCEDURE AND URETERAL STENT IMPLANTATION. AFTER STONE CRUSHING AND EXTRACTION, THE STENT WAS PREPPED FOR PLACEMENT BY ROUTINE EXAMINATION AND STRETCHING OF THE STENT OUTSIDE THE BODY. THE STRETCHING PROCESS OF THE STENT INVOLVED STRAIGHTENING THE TWO ENDS OF THE PIGTAIL, WHILE THE USER PLANNED TO PLACE THE STENT ALONG THE WIRE GUIDE. HOWEVER, THE STENT BROKE DURING THIS PROCESS AND WAS REPLACED WITH ANOTHER STENT TO COMPLETE THE PROCEDURE. THE DEVICE DID NOT MAKE PATIENT CONTACT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. .