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

Model Number	M0061921240
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter title: manager clinical projects - procurement.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during an unknown procedure, performed on (b)(6) 2021.During the procedure, when the physician tried to insert the polaris ultra stent, the stent broke.The physician tried several times with stent sheath continuously breaking.No further information was reported if a new stent was used to complete the procedure.It was reported that there was a minor injury to patient or staff.No treatment was reported to the patient or staff.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block e1: initial reporter title: manager clinical projects - procurement block h6: medical device problem code a0401 captures the reportable event of stent shaft break.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.Additional information received on (b)(6) 2021 after submitting initial report.Fields b5 (describe event or problem), d7a (sud reprocessed and reused), h6 (patient code), h6 (impact code), h8 (usage of device).
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during an unknown procedure, performed on (b)(6), 2021.During the procedure, when the physician tried to insert the polaris ultra stent, the stent broke.The physician tried several times with stent sheath continuously breaking.No further information was reported if a new stent was used to complete the procedure.It was reported that there was a minor injury to patient or staff.No treatment was reported to the patient or staff.** additional information received on (b)(6), 2021 ** another polaris ultra ureteral stent was opened and successfully completed the procedure.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: 11622967
• Report Number: 3005099803-2021-01484
• Device Sequence Number: 3085960
• Product Code: FAD
• UDI-Device Identifier: 08714729124344
• UDI-Public: 08714729124344
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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: 02/13/2021
• Device Model Number: M0061921240
• Device Catalogue Number: 192-124
• Device Lot Number: 0021742124
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1