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

Model Number M0061921320

Device Problems Calcified (1077); Difficult to Remove (1528)

Patient Problems Micturition Urgency (1871); Pain (1994); Urinary Frequency (2275); Discomfort (2330)

Event Date 12/22/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a previously implanted polaris ultra ureteral stent was removed from the patient during a nephroscopy procedure performed on (b)(6) 2021.The stent was implanted about 6 months.On (b)(6) 2021, the patient returned to the hospital for reexamination because the patient felt left-sided lumbar pain started on (b)(6) 2021.On (b)(6) 2021 a cystoscopy was performed and the stone was seen at the end of the ureter.After holmium laser lithotripsy, the double j-tube could not be removed.Also, after percutaneous nephrolithotripsy, it showed the presence of stones at the end of the double j-tube in the kidney.The calcified stent was completely removed from the patient through the nephroscope.It was reported that a polaris ultra ureteral stent was implanted.The condition of the patient at the conclusion of the removal procedure was reported to have no complication.

Manufacturer Narrative

(b)(6).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.

Manufacturer Narrative

Block h6: medical device code a150207 captures the reportable event of stent difficult to remove.Patient code e2330 captures the reportable issue of pain.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.Block h11: correction to h6: additional patient code urinary urgency.

Event Description

It was reported to boston scientific corporation that a previously implanted polaris ultra ureteral stent was removed from the patient during a nephroscopy procedure performed on (b)(6), 2021.The stent was implanted about 6 months.On (b)(6), 2021, the patient returned to the hospital for reexamination because the patient felt left-sided lumbar pain started on (b)(6), 2021.On (b)(6), 2021 a cystoscopy was performed and the stone was seen at the end of the ureter.After holmium laser lithotripsy, the double j-tube could not be removed.Also, after percutaneous nephrolithotripsy, it showed the presence of stones at the end of the double j-tube in the kidney.The calcified stent was completely removed from the patient through the nephroscope.It was reported that a polaris ultra ureteral stent was implanted.The condition of the patient at the conclusion of the removal procedure was reported to have no complication.

• Brand Name: POLARIS ULTRA
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13309104
• MDR Text Key: 288996436
• Report Number: 3005099803-2022-00168
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124429
• UDI-Public: 08714729124429
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K010002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2022

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: 06/08/2023
• Device Model Number: M0061921320
• Device Catalogue Number: 192-132
• Device Lot Number: 0025573120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/31/2021
• Initial Date FDA Received: 01/20/2022
• Supplement Dates Manufacturer Received: 01/24/2022
• Supplement Dates FDA Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR