SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

Additional Manufacturer Narrative

. E3 = SR. CLINICAL RISK ADVISOR; ALBERTA MEDICAL DEVICE SAFETY PROGRAM 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

AS REPORTED, THE 'SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT' CONTAINED DEPOSITS/CALCIFICATIONS. URETHRAL STENT PLACEMENT WAS FOLLOWING KIDNEY TRANSPLANT. THE STENT WAS IMPLANTED ON (B)(6) 2025 AND REMOVED ON (B)(6) 2025. UPON REMOVAL, THE UROLOGIST NOTED THE STENT WAS COVERED IN DEBRIS, WITH DEPOSITS ANCHORED TO THE DEVICE. THE SURGEON SUBMITTED THE DEVICE TO PATHOLOGY FOR IDENTIFICATION OF THE STONE/DEPOSIT MATERIAL. ULTRASOUND FINDINGS NOTED THE URETERIC STENT IN SITU WITH ASSOCIATED UROTHELIAL THICKENING, AS WELL AS A LEFT LOWER QUADRANT DRAIN IN SITU. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.