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

Model Number	M006155232090
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 or Problem Description
It was reported to boston scientific corporation that a polaris¿ loop ureteral stent was implanted in the ureter on (b)(6) 2017.On (b)(6) 2017, it was found that the loop of the stent migrated in the urethra.The patient manually pulled out the stent and was successfully removed.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.
Additional Manufacturer Narrative
Visual inspection of the returned device found no defects, anomalies or damages.The reported event of "stent migration" could not be confirmed through product analysis.The returned device has no visual or physical defects, anomalies or damages.Therefore, the most probable cause for this complaint is "anticipated procedure complication" since the complaint is due to a known physiological effects of the procedure noted within the directions for use (dfu).A review of the device history record (dhr) was performed and no anomalies were noted.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¿ loop ureteral stent was implanted in the ureter on (b)(6) 2017.On (b)(6) 2017, it was found that the loop of the stent migrated in the urethra.The patient manually pulled out the stent and was successfully removed.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¿ LOOP
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6412194
• Report Number: 3005099803-2017-00704
• Device Sequence Number: 10770841
• Product Code: FAD
• UDI-Device Identifier: 08714729765516
• UDI-Public: (01)08714729765516(17)20181231(10)0019032065
• Combination Product (Y/N): N
• PMA/510(K) Number: K030503
• 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): 02/24/2017

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: 12/31/2018
• Device Model Number: M006155232090
• Device Catalogue Number: 155-232-09
• Device Lot Number: 19032065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2017
• Supplement Report FDA Received Date: 03/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1