MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION POLARIS LOOP; STENT, URETERAL

Model Number	M0061552220
Medical Device Problem Codes	Break (1069); Calcified (1077)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patients exact age was not reported, however it was reported that the patient is over the age of 18.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 loop stent was removed from the ureter of a patient during a planned lithotomy under flexible ureteroscope procedure performed on (b)(6) 2018.The stent was implanted on (b)(6) 2018.According to the complainant, during withdrawal, it was noticed that the stent was covered with stone.The entire stent was removed with the use of forceps.After removal of the calcified stent, there was no new stent implanted.It was reported that although it was found calcified, the stent was able to drain.The patient was also reported to have underwent regular checkups with the stent.There were no serious injuries nor were there any adverse patient effects reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Updated: (b)(4).Block: a polaris loop stent was returned for evaluation.A visual evaluation of the returned device found that there were residues of calcification found along the distal end (pigtail) and along the proximal end (loops).The stent was received separated in three sections, also one loop was found to be torn.No other anomalies were noted.Based on the product analysis, the stent was separated and its loop was found torn; however, based on the information available the stent was reported to be removed with forceps.Therefore, it is the most likely that the reason of the stent separation and loop torn was the interaction of the stent with the forceps used.Additionally, the complaint for the event of calcification is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.Therefore the most probable root cause for this event is adverse event related to patient condition.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.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop stent was removed from the ureter of a patient during a planned lithotomy under flexible ureteroscope procedure performed on (b)(6) 2018.The stent was implanted on (b)(6) 2018.According to the complainant, during withdrawal, it was noticed that the stent was covered with stone.The entire stent was removed with the use of forceps.After removal of the calcified stent, there was no new stent implanted.It was reported that although it was found calcified, the stent was able to drain.The patient was also reported to have underwent regular checkups with the stent.There were no serious injuries nor were there any adverse patient effects reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be stable.

• Brand Name: POLARIS LOOP
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8005416
• Report Number: 3005099803-2018-61010
• Device Sequence Number: 11090705
• Product Code: FAD
• UDI-Device Identifier: 08714729421023
• UDI-Public: 08714729421023
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030503
• 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): 12/03/2018

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: 05/13/2021
• Device Model Number: M0061552220
• Device Catalogue Number: 63840
• Device Lot Number: 0022115216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Received by Manufacturer: 09/29/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1