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

Model Number M0061921320

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A polaris ultra stent was returned for evaluation.A visual evaluation of the returned device found that it was damaged at the proximal end.The stent was found detached.The suture string was not returned for analysis.Based on the product analysis, the failure encountered of stent detached, may have been related to the suture string manipulation during the suture removal.The failure of stent detached found, is consistent with one caused when the suture is being pulled incorrectly or with a excess of force.Therefore, a conclusion code of "cause traced to component failure" was assigned to this complaint since it is expected or random component failure without any design or manufacturing issue.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.

Event Description

It was reported to boston scientific corporation that a polaris ultra stent was to be used for a ureteral stenting procedure performed in the left ureter on (b)(6) 2018.According to the complainant, during preparation, the stent was reported to be damaged when they were attempting to cut the suture on the tip of the bladder side.The procedure was completed with another polaris ultra stent.There were no patient complications reported as a result of this event.The patients condition at the conclusion of the procedure was noted to be good.This event has been deemed an mdr-reportable event based on investigation results which revealed that the stent was broken.

• 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 DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol,; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8178730
• MDR Text Key: 130896135
• Report Number: 3005099803-2018-62091
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124429
• UDI-Public: 08714729124429
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 12/19/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2019
• Device Model Number: M0061921320
• Device Catalogue Number: 192-132
• Device Lot Number: 0019753901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2016
• 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
• Patient Age: 59 YR