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

Model Number	M006193132090
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: approximated based on the date the manufacturer became aware of the event.(b)(6).(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was open to be used during a procedure on an unknown date.According to the complainant, prior to procedure, when they opened the package, it was noticed that the inside box of the stent was found to be opened, the seal was peeled off.Another polaris ultra ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block e1: initial reporter facility name: (b)(6).Initial reporter address 1: (b)(6).Initial reporter state: (b)(6).Block h6: device code 1444 captures the reportable code of packaging seal compromised.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the original box with the closure strip was opened.All the device were found with the original pouch un-opened.The reported event was not confirmed.The investigation concluded that the device returned in its original outer box already open and the integrity of the device inside it is without issues and with the original pouch sealed.It is possible that the way in which the device was handled and manipulated may have contributed to the encountered failure in the polaris ultra device box (closure strip opened) and the defect noted may appear due to some aspect of shipping/ handling/ storage of the product.The closure strip found open belongs to the outer package and the device inside was found inside the original pouch sealed.Therefore, cause traced to transport/storage is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was open to be used during a procedure on an unknown date.According to the complainant, prior to procedure, when they opened the package, it was noticed that the inside box of the stent was found to be opened, the seal was peeled off.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: 10458943
• Report Number: 3005099803-2020-03552
• Device Sequence Number: 16878663
• Product Code: FAD
• UDI-Device Identifier: 08714729762911
• UDI-Public: 08714729762911
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

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: 11/30/2020
• Device Model Number: M006193132090
• Device Catalogue Number: 193-132-09
• Device Lot Number: 0021851428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1