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

Model Number M0061921310

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteral stent placement procedure performed on (b)(6) 2022.During withdrawal of the stent pusher, the radio opaque (ro) marker band attached at the tip of the stent pusher fell off.The ro marker band got stuck in the working channel of the cystoscope.After the procedure, the ro marker band was able to be removed from the scope.There were no patient complications reported as a result of this event.

• 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: 15611144
• MDR Text Key: 301848774
• Report Number: 3005099803-2022-05904
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124405
• UDI-Public: 08714729124405
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0061921310
• Device Catalogue Number: 192-131
• Device Lot Number: 0027285586
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• 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