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

Model Number	M006192122080
Medical Device Problem Codes	Unsealed Device Packaging (1444); Detachment of Device or Device Component (2907); Packaging Problem (3007); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint device has not been returned, however, a photo was provided that show one polaris ultra box with the front label ripped.The ripped is necessary to open the box.A photo of the device pouch was not provided.No other issues with the device were noted.The reported event was not confirmed.According to the product conclusion, the envelope was damaged and already broken could not be determined with the picture provided and due to the complaint device was not returned, not product analysis could be performed in the device.If the complaint device returned later, the investigation will be opened in order to address the additional evidence.Therefore, cause not established 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 to boston scientific corporation that a polaris ultra ureteral stent was attempted to be used during a ureteroscopy procedure in the kidney, performed on (b)(6) 2021.During unpacking, when the sterile pouch was noticed to be broken and the sterility of the device has been compromised.Another polaris ultra ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.A photo of the complaint device was provided and showed that the outer box was ripped, however, additional information was received stating that the inner pouch was damaged and broken.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was attempted to be used during a ureteroscopy procedure in the kidney, performed on (b)(6) 2021.During unpacking, when the sterile pouch was noticed to be broken and the sterility of the device has been compromised.Another polaris ultra ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.A photo of the complaint device was provided and showed that the outer box was ripped, however, additional information was received stating that the inner pouch was damaged and broken.
Additional Manufacturer Narrative
Block h6: medical device problem code a020503 captures the repotable event of sterility compromised.Block h10: the polaris ultra box without the pouch of the stent was returned, only a piece of the front box.A visual evaluation of the polaris ultra ureteral stent noted that the bladder pigtail was detached, the bladder pigtail section and suture hole were observed torn.The suture string was not returned for the analysis, and the positioner was found in good conditions.A photo was provided that showed one polaris ultra box with the front label ripped.The ripped is necessary to open the box.A photo of the device pouch was not provided.No other issues with the device were noted.The reported event was not confirmed.According to the product conclusion, it was possible to observe that the stent had the bladder pigtail detached, the bladder pigtail section torn and suture hole torn this types of failures could have been cause due to an excess of force applied when unpackaging the device, by the handling, manipulation and/or interaction with the suture string.This allegations will be classified as "adverse event related to procedure".This investigation assigned a conclusion code of cause not established since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.This code was selected as the most probable complaint cause based on the information available.The product record review confirmed that this is not a new failure type and the risk is anticipated.There is no evidence of a manufacturing issue, design or user issue which could have caused the complaint.As per external support form it was concluded that the process has robust controls to avoid this types of failure, there were no scrap or quality events observed rekated to this issue, therefore it is concluded that this event is not related to manufacturing process.Therefore, cause not established 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.A search of the complaint database confirmed that no similar complaints exist for the specified lot.

• Brand Name: POLARIS ULTRA
• Common Device Name: 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: 12492535
• Report Number: 3005099803-2021-04849
• Device Sequence Number: 4082025
• Product Code: FAD
• UDI-Device Identifier: 08714729815716
• UDI-Public: 08714729815716
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

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: 12/18/2023
• Device Model Number: M006192122080
• Device Catalogue Number: 192-122-08
• Device Lot Number: 0026866506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown