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

Model Number	M0061921420
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra stent was removed during a catheter removal procedure performed in the ureter on (b)(6) 2018.The stent had been previously implanted on (b)(6) 2018.According to the complainant, during the procedure, the physician noticed that the stent was calcified inside the patient.The calcification was broken up through the use of laser, and the stent was removed in its entirety.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¿.
Additional Manufacturer Narrative
A polaris stent was received for analysis.A visual evaluation found residues of calcification along the length of the entire device.No other anomalies or damages were noted.The complaint of stent calcified was confirmed.Based on the available information, the most probable cause of this complaint is "anticipated procedural complication" since the complaint is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra stent was removed during a catheter removal procedure performed in the ureter on (b)(6) 2018.The stent had been previously implanted on (b)(6) 2018.According to the complainant, during the procedure, the physician noticed that the stent was calcified inside the patient.The calcification was broken up through the use of laser, and the stent was removed in its entirety.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
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7441064
• Report Number: 3005099803-2018-01165
• Device Sequence Number: 19217321
• Product Code: FAD
• UDI-Device Identifier: 08714729124542
• UDI-Public: 08714729124542
• Combination Product (Y/N): N
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/10/2020
• Device Model Number: M0061921420
• Device Catalogue Number: 192-142
• Device Lot Number: 0020273615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Initial Date Received by Manufacturer: 03/31/2018
• Supplement Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 06/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR