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	02/08/2017
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 ureteral stent was implanted in the ureter on (b)(6) 2016 and was removed during a ureteroscopy procedure performed on (b)(6) 2017.According to the complainant, during stent withdrawal, the stent was noted to be calcified.The procedure was completed with another polaris¿ ultra ureteral stent.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 visual analysis of the returned device revealed residues of calcification at the renal and bladder pigtail of the stent.The evaluation found that the stent was calcified causing a difficultly during withdrawal of the device.Therefore, based on all available/gathered information, the most probable cause for this complaint is ¿anticipated procedural complication¿ since the complaint is due to a known physiological effects of the procedure noted within the directions for use.The device history record (dhr) review found the device met all manufacturing specifications.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 ureteral stent was implanted in the ureter on (b)(6) 2016 and was removed during a ureteroscopy procedure performed on (b)(6) 2017.According to the complainant, during stent withdrawal, the stent was noted to be calcified.The procedure was completed with another polaris¿ ultra ureteral stent.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: 6373081
• Report Number: 3005099803-2017-00512
• Device Sequence Number: 13705051
• Product Code: FAD
• UDI-Device Identifier: 08714729124542
• UDI-Public: (01)08714729124542(17)20190505(10)19207020
• Combination Product (Y/N): N
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2017

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: Physician
• Device Expiration Date: 05/05/2019
• Device Model Number: M0061921420
• Device Catalogue Number: 192-142
• Device Lot Number: 19207020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2017
• Supplement Report FDA Received Date: 04/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 93