MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) POLARIS¿ ULTRA; STENT, URETERAL

Model Number M006193133090

Device Problems Calcified (1077); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2016

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a polaris¿ ultra ureteral stent that had been implanted in the kidney for approximately four months was removed on (b)(6) 2016.According to the complainant, during stent withdrawal, the kidney side pigtail of the stent did not extend.It was noted that the stent was calcified.A guidewire was used in the attempt to straighten the pigtail, but it was unsuccessful as the guidewire could not pass through the lumen.A rigid urethroscope was inserted in order to view, remove the calculus, and then successfully remove the stent from the patient.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

Manufacturer Narrative

A visual analysis of the returned device has found a black color appearance with evidence of calcification at the renal pigtail section.The evaluation revealed that the stent was calcified.During manufacturing, devices were inspected to ensure that all finished devices meet specifications.Most likely, the issue could have been generated when the device remains in the patient's body for a certain time.Therefore, the most probable root cause assigned to the complaint is "anticipated procedural complication".

Event Description

It was reported to boston scientific corporation that a polaris¿ ultra ureteral stent that had been implanted in the kidney for approximately four months was removed on (b)(6) 2016.According to the complainant, during stent withdrawal, the kidney side pigtail of the stent did not extend.It was noted that the stent was calcified.A guidewire was used in the attempt to straighten the pigtail, but it was unsuccessful as the guidewire could not pass through the lumen.A rigid urethroscope was inserted in order to view, remove the calculus, and then successfully remove the stent from the patient.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

• Brand Name: POLARIS¿ ULTRA
• 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: 6049668
• MDR Text Key: 58131974
• Report Number: 3005099803-2016-03096
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K010002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M006193133090
• Device Catalogue Number: 193-133-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1