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

Model Number	M006192123090
Medical Device Problem Codes	Calcified (1077); Difficult to Remove (1528); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2020 based on the date the manufacturer became aware of the event.Initial reporter state: (b)(6).(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 previously implanted polaris ultra ureteral stent was removed from the patient's ureter on an unknown date.The stent was implanted for about 3 months.According to the complainant, during the planned stent removal procedure, a cut/break was felt around the center part of the stent, around 12mm from both ends of the stent.Reportedly, the stent was successfully explanted and another polaris ultra ureteral stent was placed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: date of event was approximated to (b)(6) 2020 based on the date the manufacturer became aware of the event.Block e1: initial reporter state: shiga prefecture.Block h6: device code 4008 captures the reportable event of stent torn material upon removal.Device code 1528 captures the reportable event of stent difficult to remove upon removal.Device code 1077 captures the reportable investigation results of stent calcified.Block h10: the returned polaris ureteral stent was analyzed, and a visual evaluation noted that residues of calcification were found along of the proximal end (bladder pigtail).The stent does not present any section broken or damaged.A functional inspection was performed, a mandrel 0.035" was inserted through the catheter and some resistance was felt due to the calcification residues.A microscope inspection was performed, it was observed to have residues inside the bladder pigtail section.The reported event of stent torn material was not confirmed, however; according to the analysis, the device was calcified in several sections; moreover, based on the information available the stent was removed with difficulties and the calcification condition will affect the device removal process.Therefore, the most probable root cause is known inherent risk of device.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a previously implanted polaris ultra ureteral stent was removed from the patient's ureter on an unknown date.The stent was implanted for about 3 months.According to the complainant, during the planned stent removal procedure, a cut/break was felt around the center part of the stent, around 12mm from both ends of the stent.Reportedly, the stent was successfully explanted and another polaris ultra ureteral stent was placed.There were no patient complications reported as a result of this event.

• Brand Name: POLARIS ULTRA
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9820562
• Report Number: 3005099803-2020-00848
• Device Sequence Number: 1568274
• Product Code: FAD
• UDI-Device Identifier: 08714729124337
• UDI-Public: 08714729124337
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

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: 05/28/2022
• Device Model Number: M006192123090
• Device Catalogue Number: 192-123-09
• Device Lot Number: 0024195821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1