FDA Adverse Event Malfunction Summary report: N

NAVIGATOR

MDR report key: 2141586 · Received June 10, 2011

Report

Report Number
2141586
Event Type
Malfunction
Date Received
June 10, 2011
Date of Event
April 15, 2011
Report Date
June 10, 2011
Manufacturer
BOSTON SCIENTIFIC
Product Code
EYB
Product Problem
Yes
Report Source
User Facility report
Reporter Location
ME, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

THE PT HAD PAIN SIX MONTHS AGO TOWARD HIS LEFT SIDE, BUT THE CT SCAN OF HIS ABDOMEN SHOWED A 7.4 MM CALCULUS IN THE RIGHT PROXIMAL URETER WITHOUT SIGNIFICANT HYDRONEPHROSIS, BUT WITH PAIN. HE WAS ON ANALGESICS BECAUSE THE HYDRONEPHROSIS WAS MILD ONLY, BUT IT RECURRED, AS WELL AS NAUSEA AND ALMOST VOMITING. HE IS BROUGHT BACK AT THIS TIME FOR MORE DEFINITIVE THERAPY OF HIS HIGH URETERAL CALCULUS. THE PT WAS ADMITTED FOR A CYSTOSCOPY, RIGHT URETEROSCOPY AND LASER LITHOTRIPSY. HE HAD A RIGHT URETERAL STENT PLACED. DURING THE PROCEDURE, THE NAVIGATOR URETERAL ACCESS SHEATH WAS INSERTED AND A LONG SEMI-RIGID URETEROSCOPE WAS INSERTED THROUGH THE SHEATH. THE URETEROSCOPE WENT THROUGH THE SHEATH MAKING A HOLE IN THE SHEATH. THE OLD STENT WAS REMOVED. OVER THE SUPERSTIFF WAS THEN PLACED A NAVIGATOR, AND UNDER THE C-ARM CONTROL, WAS PLACED INTO THE LOWER URETER, BUT THERE WAS ANGULATION AND SO THE NAVIGATOR WAS REMOVED AND IT WAS NOTICED THAT THE END OF THE SCOPE HAD GONE THROUGH THE END OF THE NAVIGATOR DESPITE THE FACT THAT THE SUPERSTIFF WIRE WAS WITHIN. THERE WAS SOME TRAUMA TO THE URETER. A SEMI-RIGID URETEROSCOPE WAS INTRODUCED OVER THE WORKING WIRE AND BROUGHT UP INTO THE UPPER URETER WITHOUT DIFFICULTY. THE STONE WAS VISUALIZED AND WAS IMBEDDED IN THE MEDIAL WALL OF THE URETER. THE STONE WAS DISRUPTED WITH LASER AND ASSISTANCE OF AN ESCAPE STONE BASKET AND FIBER. THE FIBERS WERE REMOVED AND A 7-FRENCH 2230 CONTOUR DOUBLE-J STENT WAS THEN PLACED OVER THE SAFETY WIRE WITHOUT DIFFICULTY INTO ITS PROPER POSITION WITH A GOOD CURL IN THE RIGHT RENAL PELVIS AND INTO THE BLADDER. BECAUSE OF THE TRAUMA TO THE LOWER URETER, THIS STENT WILL BE LEFT IN FOR THREE TO FOUR WEEKS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 NAVIGATOR URETERAL ACCESS SHEATH EYB BOSTON SCIENTIFIC SHEATH, ACCESS, URETERAL 13/15FR X 46 CM 316915

Patients

Seq Age Sex Outcome Treatment
1 36 YR