MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) MODIFICATION TO CONTOUR POLARIS URETERAL STENT; STENT, URETERAL

Model Number UNK412

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 11/03/2015

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

Note: this report pertains to one of five complaint devices used in the same procedure.Manufacturer report # 3005099803-2015-03327 addresses the navigator hd, while manufacturer report # 3005099803-2015-03387 and 3005099803-2015-03388 addresses the 2 flexiva laser fibers, manufacturer report # 3005099803-2015-03384 addresses the graspit forceps and manufacturer report # 3005099803-2015-03396 addresses the ureteral stent.It was reported to boston scientific corporation that a navigator hd, 2 flexiva laser fibers, a graspit forcep and a stent was used during a lithotripsy procedure performed on (b)(6) 2015.According to the complainant, towards the end of the procedure after breaking the stone, the physician attempted to place the stent and experienced difficulty in advancing.The deployment of stent was stopped and the physician injected a dye to check placement.It was then noted that the patient's ureter was perforated.The exact cause of perforation is unknown.Reportedly, there was no alleged malfunction noted to the devices.Boston scientific has been unable obtain additional information regarding the circumstances surrounding this event.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: MODIFICATION TO CONTOUR POLARIS URETERAL STENT
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5247948
• MDR Text Key: 32086979
• Report Number: 3005099803-2015-03396
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other