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

Model Number M0061903220

Device Problem Calcified (1077)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a tria ureteral stent was used during a ureteroscopy procedure in the kidney, performed on (b)(6) 2021.Post procedure, the patient was being seen for a second look treatment for residual stones.When the physician brought the patient to the operating room for treatment, the first stent was removed and was found to be calcified.The calcified stent was removed and another tria ureteral stent was implanted and successfully completed the procedure.The patient complained that the stent was very uncomfortable and there was pain.The patient's condition at the conclusion of the procedure was reported to have fully recovered.

• Brand Name: TRIA SOFT
• 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: 12415083
• MDR Text Key: 270640871
• Report Number: 3005099803-2021-04404
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729959892
• UDI-Public: 08714729959892
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2024
• Device Model Number: M0061903220
• Device Catalogue Number: 1983-02
• Device Lot Number: 0027148019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2021
• 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: 69 YR