URETERAL INDWELLING CATHETER/STENT

Report

Report Number: 3005099803-2010-04292
Event Type: Injury
Date Received: October 12, 2010
Date of Event: August 25, 2010
Report Date: September 21, 2010
Manufacturer: BOSTON SCIENTIFIC - SPENCER
Product Code: FAD
PMA / PMN Number: K974541
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

ANALYSIS OF THE RETURNED CONTOUR VL INJECTION STENT REVEALED THE STENT WAS DEFORMED. THE STENT WAS COLLAPSED IN SEVERAL LOCATIONS. THE PROXIMAL AND DISTAL ENDS OF THE STENT WERE ALSO COLLAPSED. THE DISTAL CURLS OF THE STENT WERE COLLAPSED, AND THERE WAS A CRACK/SPLIT IN THE COLLAPSED AREA OF THE STENT AT 14.5CM FROM THE DISTAL END; THE CRACK DID NOT GO ALL OF THE WAY THROUGH THE STENT WALL. THE STENT WAS KINKED AND BENT. A 0.035" SENSOR GUIDEWIRE WOULD NOT PASS FREELY THROUGH THE STENT. THERE IS NOTHING PRESENT ON THE STENT THAT SHOULD HAVE CAUSED A LACERATION OF THE URETER. THERE WERE NO SHARP EDGES. THE COLLAPSED AREAS OF THE STENT ARE CONSISTENT WITH BEING SMASHED DURING PREPARATION FOR RETURN OR DURING TRANSIT. IT SHOULD BE NOTED THAT THE INJECTION POSITIONER AND RELEASE SLEEVE WERE ALSO PRESENT IN AN UNOPENED, LABELED POUCH; IT DOES NOT APPEAR THAT THEY WERE USED IN THE PROCEDURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; THE ACCEPTED DEVICE MET ALL MANUFACTURING SPECIFICATIONS. SINCE THE SPECIFIC CAUSE OF THE DAMAGE TO THE STENT CANNOT BE DETERMINED, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS UNDETERMINABLE.

Additional Manufacturer Narrative · 1

THE PHYSICIAN REPORTED THAT THE PATIENT WAS IN GOOD CONDITION AND THE URETER WAS FINE. HOWEVER, CYSTOSCOPY WAS NOT PERFORMED.

Additional Manufacturer Narrative · 1

ALTHOUGH EXPECTED, THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. 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 MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL INJECTION URETERAL STENT WAS BEING PLACED FOLLOWING A URETEROSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, WHEN THE DOCTOR BEGAN TO INTRODUCE THE STENT INTO THE URETER, THE STENT LACERATED THE PATIENT'S URETER. THE DISTAL END OF THE STENT APPEARED TO HAVE A 'RAGGED' EDGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND CONTOUR VL INJECTION URETERAL STENT. THE PATIENT WAS REPORTED TO BE "STABLE" AT THE CONCLUSION OF THE PROCEDURE.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL INJECTION URETERAL STENT WAS BEING PLACED FOLLOWING A URETEROSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, WHEN THE DOCTOR BEGAN TO INTRODUCE THE STENT INTO THE URETER, THE STENT LACERATED THE PATIENT'S URETER. THE DISTAL END OF THE STENT APPEARED TO HAVE A 'RAGGED' EDGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND CONTOUR VL INJECTION URETERAL STENT. THE PATIENT WAS REPORTED TO BE "STABLE" AT THE CONCLUSION OF THE PROCEDURE.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL INJECTION URETERAL STENT WAS BEING PLACED FOLLOWING A URETEROSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, WHEN THE DOCTOR BEGAN TO INTRODUCE THE STENT INTO THE URETER, THE STENT LACERATED THE PATIENT'S URETER. THE DISTAL END OF THE STENT APPEARED TO HAVE A 'RAGGED' EDGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND CONTOUR VL INJECTION URETERAL STENT. THE PATIENT WAS REPORTED TO BE "STABLE" AT THE CONCLUSION OF THE PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	URETERAL INDWELLING CATHETER/STENT	STENT, URETERAL	FAD	BOSTON SCIENTIFIC - SPENCER	M0061856290	0013137911

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR		Other