Percuflex Nephroureteral Stent

Description of Event or Problem

IT WAS REPORTED THAT STENT BREAK AND KINK OCCURRED, REQUIRING ADDITIONAL INTERVENTION. A (B)(6) PERCUFLEX I/E NEPHROURETERAL STENT WAS SELECTED FOR USE. A PATIENT REQUIRED THE SAME PROCEDURE ON THREE SEPARATE OCCASIONS, EACH APPROXIMATELY FOUR WEEKS APART OVER A THREE-MONTH PERIOD DUE TO DENTING, KINKING, AND FRACTURING OF THE DEVICE, WHICH ULTIMATELY LED TO URINE LEAKAGE THROUGH THE SKIN PRIOR TO THE PATIENT'S MOST RECENT VISIT. IT WAS NOTED THAT UPON OPENING THE DEVICE, A SMALL BUT NOTICEABLE DENT WAS OBSERVED. THE PRODUCT PACKAGING ITSELF WAS INTACT AND SHOWED NO SIGNS OF DAMAGE. THE DEVICE WAS EXPLANTED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. FURTHER DETAILS ABOUT THE DEVICE COULD NOT BE CONFIRMED THROUGH GFE, AS THE FACILITY DISCARDED THE DEVICE. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.