FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
Received May 7, 2026 · Event occurred Dec 21, 2025
Report 1820334-2026-00493 · MDR key 25110412
Device
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E1 TITLE: PURCHASING. 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 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 HAS BEEN REPORTED THAT THE DISTAL END OF THE STENT INCLUDED IN THE 'FILIFORM DOUBLE PIGTAIL URETERAL STENT SET' WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT AS THE BROKEN DEVICE WAS DISCOVERED AT A DISTRIBUTION CENTER.