URETERAL ACCESS SHEATH SET (UASS)

Report

Report Number: 3005099803-2011-02888
Event Type: Injury
Date Received: August 25, 2011
Date of Event: April 15, 2011
Report Date: September 17, 2011
Manufacturer: BOSTON SCIENTIFIC - MARLBOROUGH
Product Code: KOD
PMA / PMN Number: K022135
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: ME, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

THE LOT NUMBER IS NOT KNOWN PER COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CAN NOT BE DETERMINED. DEVICE AVAILABLE FOR EVALUATION: RECEIVED, NOT YET EVALUATED THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE HAVE NOT YET DETERMINED THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MANUFACTURER'S REPORT WILL BE FILED.

Additional Manufacturer Narrative · 1

THE PRELIMINARY ANALYSIS OF THE NAVIGATOR URETERAL ACCESS SHEATH REVEALED THE DEVICE WAS RETURNED IN 2 PIECES. HOWEVER, THE COMPLAINT SAMPLE WAS INADVERTENTLY MISPLACED BEFORE A FULL INVESTIGATION WAS COMPLETED. NO FULL PRODUCT ANALYSIS WAS ABLE TO BE PERFORMED. THEREFORE, THE ROOT CAUSE FOR THIS EVEN IS DETERMINE TO BE "UNDERTERMINABLE". IF THE COMPLAINT SAMPLE IS LOCATED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN FG NAVIGATOR URETERAL ACCESS SHEATH SET WAS USED IN A COMBINED CYSTOSCOPY, RIGHT URETEROSCOPY, AND LASER LITHOTRIPSY PROCEDURE ON (B)(6) 2011. THE PATIENT WAS REPORTED TO BE A MALE, (B)(6). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A SUPER-STIFF WIRE WAS PLACED INTO THE LOWER URETER UNDER THE C-ARM CONTROL. A NAVIGATOR SHEATH WAS THEN PLACED OVER THE WIRE FOLLOWED BY A LONG SEMI - RIGID URETEROSCOPE INSERTED THROUGH THE SHEATH. THE ANATOMY WAS OBSERVED TO BE TOO TORTUOUS, SO THE NAVIGATOR WAS REMOVED. AFTER IT WAS REMOVED, IT WAS NOTICED THAT THE END OF THE SCOPE HAD GONE THROUGH THE END OF THE NAVIGATOR DESPITE THE FACT THAT THE SUPER-STIFF WIRE HAS BEEN PLACED. THE URETEROSCOPE PERFORATED THE SHEATH MAKING A HOLE. SOME TRAUMA TO THE URETER WAS NOTED. A SEMI-RIGID URETEROSCOPE WAS THEN INTRODUCED OVER THE WORKING WIRE AND BROUGHT UP INTO THE UPPER URETER WITHOUT DIFFICULTY. THE STONE WAS VISUALIZED AND SEEN TO BE IMBEDDED IN THE MEDIAL WALL OF THE URETER. THE STONE WAS FRAGMENTED WITH LASER AND ASSISTANCE OF AN ESCAPE STONE RETRIEVAL BASKET AND LASER FIBER. THE FIBERS WERE REMOVED AND A 7-FRENCH 2230 CONTOUR DOUBLE-J STENT WAS THEN PLACED OVER THE SAFETY WIRE WITHOUT DIFFICULTY. IT WAS PLACED INTO ITS PROPER POSITION IN THE RIGHT RENAL PELVIS AND INTO THE BLADDER WITH A GOOD CURL. BECAUSE OF THE TRAUMA TO THE LOWER URETER, THE STENT WAS LEFT IN THE PATIENT FOR APPROXIMATELY FOUR WEEKS. THE PATIENT RETURNED FOR FOLLOW UP AT THAT TIME AND THE STENT WAS REMOVED. THE PATIENT HAD NO FURTHER COMPLICATIONS AND IS DOING WELL.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN FG NAVIGATOR URETERAL ACCESS SHEATH SET WAS USED IN A COMBINED CYSTOSCOPY, RIGHT URETEROSCOPY, AND LASER LITHOTRIPSY PROCEDURE ON (B)(6), 2011. THE PATIENT WAS REPORTED TO BE A (B)(6). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A SUPER-STIFF WIRE WAS PLACED INTO THE LOWER URETER UNDER THE C-ARM CONTROL. A NAVIGATOR SHEATH WAS THEN PLACED OVER THE WIRE FOLLOWED BY A LONG SEMI - RIGID URETEROSCOPE INSERTED THROUGH THE SHEATH. THE ANATOMY WAS OBSERVED TO BE TOO TORTUOUS SO THE NAVIGATOR WAS REMOVED. AFTER IT WAS REMOVED, IT WAS NOTICED THAT THE END OF THE SCOPE HAD GONE THROUGH THE END OF THE NAVIGATOR DESPITE THE FACT THAT THE SUPER-STIFF WIRE HAS BEEN PLACED. THE URETEROSCOPE PERFORATED THE SHEATH MAKING A HOLE. SOME TRAUMA TO THE URETER WAS NOTED. A SEMI-RIGID URETEROSCOPE WAS THEN INTRODUCED OVER THE WORKING WIRE AND BROUGHT UP INTO THE UPPER URETER WITHOUT DIFFICULTY. THE STONE WAS VISUALIZED AND SEEN TO BE IMBEDDED IN THE MEDIAL WALL OF THE URETER. THE STONE WAS FRAGMENTED WITH LASER AND ASSISTANCE OF AN ESCAPE STONE RETRIEVAL BASKET AND LASER FIBER. THE FIBERS WERE REMOVED AND A 7-FRENCH 2230 CONTOUR DOUBLE-J STENT WAS THEN PLACED OVER THE SAFETY WIRE WITHOUT DIFFICULTY. IT WAS PLACED INTO ITS PROPER POSITION IN THE RIGHT RENAL PELVIS AND INTO THE BLADDER WITH A GOOD CURL. BECAUSE OF THE TRAUMA TO THE LOWER URETER, THE STENT WAS LEFT IN THE PATIENT FOR APPROXIMATELY FOUR WEEKS. THE PATIENT RETURNED FOR FOLLOW UP AT THAT TIME AND THE STENT WAS REMOVED. THE PATIENT HAD NO FURTHER COMPLICATIONS AND IS DOING WELL.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN FG NAVIGATOR URETERAL ACCESS SHEATH SET WAS USED IN A COMBINED CYSTOSCOPY, RIGHT URETEROSCOPY, AND LASER LITHOTRIPSY PROCEDURE ON (B)(6), 2011. THE PATIENT WAS REPORTED TO BE A MALE, (B)(6) OF AGE, WEIGHING (B)(6). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A SUPER-STIFF WIRE WAS PLACED INTO THE LOWER URETER UNDER THE C-ARM CONTROL. A NAVIGATOR SHEATH WAS THEN PLACED OVER THE WIRE FOLLOWED BY A LONG SEMI - RIGID URETEROSCOPE INSERTED THROUGH THE SHEATH. THE ANATOMY WAS OBSERVED TO BE TOO TORTUOUS SO THE NAVIGATOR WAS REMOVED. AFTER IT WAS REMOVED, IT WAS NOTICED THAT THE END OF THE SCOPE HAD GONE THROUGH THE END OF THE NAVIGATOR DESPITE THE FACT THAT THE SUPER-STIFF WIRE HAS BEEN PLACED. THE URETEROSCOPE PERFORATED THE SHEATH MAKING A HOLE. SOME TRAUMA TO THE URETER WAS NOTED. A SEMI-RIGID URETEROSCOPE WAS THEN INTRODUCED OVER THE WORKING WIRE AND BROUGHT UP INTO THE UPPER URETER WITHOUT DIFFICULTY. THE STONE WAS VISUALIZED AND SEEN TO BE IMBEDDED IN THE MEDIAL WALL OF THE URETER. THE STONE WAS FRAGMENTED WITH LASER AND ASSISTANCE OF AN ESCAPE STONE RETRIEVAL BASKET AND LASER FIBER. THE FIBERS WERE REMOVED AND A 7-FRENCH 2230 CONTOUR DOUBLE-J STENT WAS THEN PLACED OVER THE SAFETY WIRE WITHOUT DIFFICULTY. IT WAS PLACED INTO ITS PROPER POSITION IN THE RIGHT RENAL PELVIS AND INTO THE BLADDER WITH A GOOD CURL. BECAUSE OF THE TRAUMA TO THE LOWER URETER, THE STENT WAS LEFT IN THE PATIENT FOR APPROXIMATELY FOUR WEEKS. THE PATIENT RETURNED FOR FOLLOW UP AT THAT TIME AND THE STENT WAS REMOVED. THE PATIENT HAD NO FURTHER COMPLICATIONS AND IS DOING WELL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	URETERAL ACCESS SHEATH SET (UASS)	CATHETER, UROLOGICAL	KOD	BOSTON SCIENTIFIC - MARLBOROUGH	M0062502100

Patients

Seq	Age	Sex	Outcome	Treatment
1	36 YR		Required Intervention