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

Model Number	M0061552330
Medical Device Problem Codes	Calcified (1077); Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2019
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 loop was used during a procedure in the kidney.The exact implant date was not reported, however, the stent was implanted for approximately two weeks.According to the complainant, during a planned stent removal procedure on (b)(6) 2019, it was noticed that the polaris loop was not in a straight shape when removed, causing difficulty removing from the patient.The stent was removed using a grasping forceps with local anesthesia, and the procedure was completed successfully.There was no serious injury, 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.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop was used during a procedure in the kidney.The exact implant date was not reported, however, the stent was implanted for approximately two weeks.According to the complainant, during a planned stent removal procedure on (b)(6) 2019, it was noticed that the polaris loop was not in a straight shape when removed, causing difficulty removing from the patient.The stent was removed using a grasping forceps with local anesthesia, and the procedure was completed successfully.There was no serious injury, 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
Problem code and device code 1528 captures the reportable event of stent difficult to remove.Problem code and device code 2976 captures the reportable event of material deformation during withdrawal.Investigation analysis: a polaris loop was returned for analysis.A visual evaluation of the returned device revealed that residues of calcification were found along of the distal end (pigtail) and along of the distal section (next to pigtail).The invesigation concluded that encrustation and stone formation are adverse events associated with retrograde or anterograde positioned indwelling ureteral stents.The reported adverse events are known and documented in the labeling (including both short or long term known complications or adverse reactions).Therefore, 'known inherent risk of device' is selected as the most probable root cause for the complaint.A review of the device history record (dhr) confirms that the accepted device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.

• 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: 8976913
• Report Number: 3005099803-2019-04464
• Device Sequence Number: 19657078
• Product Code: FAD
• UDI-Device Identifier: 08714729421092
• UDI-Public: 08714729421092
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K030503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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: 04/07/2022
• Device Model Number: M0061552330
• Device Catalogue Number: 155-233
• Device Lot Number: 0023610528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR