FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
Received Apr 3, 2026 · Event occurred Mar 20, 2026
Report 1820334-2026-00363 · MDR key 24778136
Device
Product problems
- Difficult to Advance
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1: PHONE (B)(6). G4 - PMA/510(K) #: PREAMENDMENT. H3: DEVICE EVALUATED BY MFG = 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 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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 DURING A RETROGRADE INTRARENAL SURGERY, THE WIRE COULD NOT BE PUSHED INTO THE STENT OF A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET. THE PROCEDURE WAS COMPLETED BY USING A NEW FILIFORM DOUBLE PIGTAIL URETERAL STENT SET. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.