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

Model Number M0061921420

Device Problem Calcified (1077)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 not been received for analysis.Upon receipt and 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 was implanted in (b)(6) 2016, was removed from the ureter during stent withdrawal procedure performed on (b)(6) 2016.According to the complainant, during the scheduled stent removal, it was found that the stent was calcified.Although the stent was found calcified, it was reportedly still be able to drain.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 stable.

Manufacturer Narrative

A visual analysis of the returned device has found evidence of calcification on both pigtails and in the middle section of the catheter.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 was implanted in (b)(6) 2016, was removed from the ureter during stent withdrawal procedure performed on (b)(6) 2016.According to the complainant, during the scheduled stent removal, it was found that the stent was calcified.Although the stent was found calcified, it was reportedly still be able to drain.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 stable.

• 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: 6028806
• MDR Text Key: 57403375
• Report Number: 3005099803-2016-03004
• 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: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: M0061921420
• Device Catalogue Number: 192-142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 10/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/29/2016
• 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
• Patient Age: 49 YR