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

Model Number	M0061921240
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact age of the patient is unknown, however it was reported that the patient was over the age of 18.Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra stent was to be used in a ureteroscopy (urs) procedure to be performed in the ureter, on (b)(6) 2019.According to the complainant, during preparation, outside the patient, it was noticed that the stent was broken at the middle part of the stent.This was noticed while the device was still in its packaging.The procedure was successfully completed with a different device.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra stent was to be used in a ureteroscopy (urs) procedure to be performed in the ureter, on (b)(6) 2019.According to the complainant, during preparation, outside the patient, it was noticed that the stent was broken at the middle part of the stent.This was noticed while the device was still in its packaging.The procedure was successfully completed with a different device.
Additional Manufacturer Narrative
The exact age of the patient is unknown, however it was reported that the patient was over the age of 18.Problem code 1069 captures the reportable event of stent shaft broken.Investigation analysis a polaris ultra stent was returned for analysis.A visual evaluation of the returned device found that the stent was broken.The shaft proximal section was detached.The stent returned with the protective tube loaded in the stent.No other anomalies were noted.Based on product analysis and all gathered information, the removal of the suture with the protective tube loaded may have resulted in the significant damage (pigtail detached); it is possible to determine that the failure encountered (shaft detached) was associated with the interaction of the stent with its suture, because handling of the suture can generate the failure found.Therefore, a conclusion code of unintended use error caused or contributed to event is being utilized for this event since the interaction between the user and device, or sample, caused or contributed to the error.This includes unintended inappropriate use of the device and incorrect sample preparation.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

• 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: 8414919
• Report Number: 3005099803-2019-01216
• Device Sequence Number: 1858885
• Product Code: FAD
• UDI-Device Identifier: 08714729124344
• UDI-Public: 08714729124344
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 04/12/2019

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: 08/07/2021
• Device Model Number: M0061921240
• Device Catalogue Number: 192-124
• Device Lot Number: 0022488388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1