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

Model Number M0061921320

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter state: (b)(6).(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a laser ureterolithotomy procedure in the kidney and ureter, performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, when the physician attempted to deploy the stent, it was noticed that the coil was detached.The guidewire completely removed the detached coil and stent.Another polaris ultra ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was noted to be good.

• 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: 10488055
• MDR Text Key: 205497173
• Report Number: 3005099803-2020-03710
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124429
• UDI-Public: 08714729124429
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K010002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2022
• Device Model Number: M0061921320
• Device Catalogue Number: 192-132
• Device Lot Number: 0024070422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2019
• 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