MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. BOSTON SCIENTIFIC POLARIS ULTRA; URETERAL STENT

Catalog Number M0061921310

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2018

Event Type  malfunction  

Event Description

Device was noted by the surgical tech to have a defect on the tail before coming to contact with the patient.Defective stent was removed from the sterile field and replaced.

• Brand Name: BOSTON SCIENTIFIC POLARIS ULTRA
• Type of Device: URETERAL STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP.; el coyol, alajuela, cr ; CS
• MDR Report Key: 7929847
• MDR Text Key: 122803027
• Report Number: MW5080294
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 9111992101
• UDI-Public: 91119921-01
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2020
• Device Catalogue Number: M0061921310
• Device Lot Number: 20407087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 81