MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRIA FIRM; STENT, URETERAL

Model Number M006190234090

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The returned tria firm ureteral stent was analyzed, and a visual evaluation noted that the stent shaft middle section detached/separated.The suture string was not returned with the device.No other issues with the device were noted.The reported event was not confirmed.The returned device was found with the stent shaft middle section detached/separated.Based on the product analysis, the failure found stent shaft detached/separated is an issue that could have been generated by the user or due to the interacting of the device with the suture string.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint since it is most likely that the adverse event occurred during the preparation and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that a tria firm ureteral stent was used during a ureteral stent placement procedure in the ureter, performed on (b)(6) 2020.According to the complainant, during preparation, when the physician attempted to remove the suture, with no force applied, it was noticed that the pigtail flap was ruptured.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of stent shaft broken.

• Brand Name: TRIA FIRM
• Type of Device: 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: 10862209
• MDR Text Key: 217141109
• Report Number: 3005099803-2020-05546
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190603
• 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: 11/18/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2022
• Device Model Number: M006190234090
• Device Catalogue Number: 1983-04
• Device Lot Number: 0025952421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2019
• 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