FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
Received May 4, 2026 · Event occurred Dec 17, 2025
Report 1820334-2026-00475 · MDR key 25069774
Device
Product problems
- Break
Patient
62 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT UPON OPENING THE PACKAGING OF A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET, THE STENT WAS OBSERVED TO BE BROKEN PRIOR TO USE DURING AN URETHRAL URETEROSCOPY AND URETERAL LASER LITHOTRIPSY PROCEDURE ON THE RIGHT SIDE. THE USER CHANGED TO A NEW STENT TO CONTINUE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Additional Manufacturer Narrative
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E1 - ADDRESS: (B)(6). G4 - PMA/510(K) #: PREAMENDMENT H3: DEVICE EVALUATED BY MFG - DEVICE EVALUATION HAS BEGUN; HOWEVER, A CONCLUSION IS NOT YET AVAILABLE. 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.