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

Model Number M0061921330

Device Problem Calcified (1077)

Patient Problems Inflammation (1932); Obstruction/Occlusion (2422)

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

Exact implant date is unknown; however it was reported that it was implanted in (b)(6) 2019.Initial reporter state/province: ba.(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 Description

It was reported to boston scientific corporation that a polaris ultra stent was implanted on (b)(6) 2019 with no issues reported during stent placement.According to the complainant, on (b)(6) 2020, the patient was admitted in the emergency room because of septic condition from ureteral calcoli and hydronephrosis.A new right ureteral stent was endourological positioned.The physician attempted to replace the left polaris ultra ureteral stent.During the procedure, it was noticed that there were excessive calcifications at the proximal part of the stent.It was reported that the left polaris ultra ureteral stent was not replaced.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block d6: exact implant date is unknown; however it was reported that it was implanted in (b)(6) 2019.Block e1: initial reporter state/province:(b)(6) block h6: paient code 2422 captures the reportable event of obstruction.Device code 1077 captures the reportable event of stent calcified.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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.Block h11: correction to field h6: patient code.

Event Description

It was reported to boston scientific corporation that a polaris ultra stent was implanted on (b)(6) 2019 with no issues reported during stent placement.According to the complainant, on (b)(6) 2020, the patient was admitted in the emergency room because of septic condition from ureteral calcoli and hydronephrosis.A new right ureteral stent was endourological positioned.The physician attempted to replace the left polaris ultra ureteral stent.During the procedure, it was noticed that there were excessive calcifications at the proximal part of the stent.It was reported that the left polaris ultra ureteral stent was not replaced.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: POLARIS ULTRA
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10145377
• MDR Text Key: 194875356
• Report Number: 3005099803-2020-02280
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124443
• UDI-Public: 08714729124443
• Combination Product (y/n): N
• PMA/PMN Number: K010002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2022
• Device Model Number: M0061921330
• Device Catalogue Number: 192-133
• Device Lot Number: 0023362044
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/21/2020
• Initial Date FDA Received: 06/11/2020
• Supplement Dates Manufacturer Received: 07/16/2020
• Supplement Dates FDA Received: 08/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR