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	05/24/2017
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 had been implanted in the ureter on (b)(6) 2017, and was removed on (b)(6) 2017 as a planned ureteroscopy procedure.According to the complainant, during stent withdrawal, it was noted that the stent was calcified and was unable to drain.A clamp was used to remove the entire stent.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 stent revealed residues of calcification on the stent, it was also found kinked at 12.0 cm from the renal pigtail.Encrustation is an adverse event associated with retrograde and antegrade positioned indwelling ureteral stents; therefore, based on all gathered information the most probable cause for this complaint is considering ¿anticipated procedural complication¿ since the complaint is due to a known physiological effects of the procedure noted within the directions for use.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.A review of the device history record (dhr) confirms that the accepted device met all manufacturing specifications.A search of the complaint database confirmed that no similar complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation that a polaris¿ ultra ureteral stent had been implanted in the ureter on (b)(6) 2017, and was removed on (b)(6) 2017 as a planned ureteroscopy procedure.According to the complainant, during stent withdrawal, it was noted that the stent was calcified and was unable to drain.A clamp was used to remove the entire stent.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: 6798875
• Report Number: 3005099803-2017-02500
• Device Sequence Number: 11022743
• Product Code: FAD
• UDI-Device Identifier: 08714729124542
• UDI-Public: (01)08714729124542(17)20190811(10)19561447
• Combination Product (Y/N): N
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2017

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: Health Professional
• Device Expiration Date: 08/11/2019
• Device Model Number: M0061921420
• Device Catalogue Number: 192-142
• Device Lot Number: 19561447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Initial Date Received by Manufacturer: 07/21/2017
• Supplement Date Received by Manufacturer: 09/04/2017
• Initial Report FDA Received Date: 08/16/2017
• Supplement Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 80