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

Model Number M006190322090

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.

Event Description

It was reported to boston scientific corporation that a tria soft ureteral stent was used during a ureteral stent placement procedure in the ureter performed on (b)(6) 2024.During the procedure, it was noted that the stent was found damaged.The procedure was successfully completed with another tria soft ureteral stent.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation that a tria soft ureteral stent was used during a ureteral stent placement procedure in the ureter performed on (b)(6) 2024.During the procedure, it was noted that the stent was found damaged.The procedure was successfully completed with another tria soft ureteral stent.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.Block h10: the returned tria ureteral stent was analyzed, and a visual and microscopic evaluation noted that the bladder coil torn in one of the drainage holes.Additionally, the positioner was not returned.No other problems with the device were noted.The reported event was not confirmed.Taking all available information into consideration, most likely, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.For the reported problem of stent shaft break, it is not confirmed due to a shaft break was not detected during the analysis.For this reason, the as analyze code will be no problem detected.These problems could have been cause due to an interaction of the device with the suture string such as entanglement, manipulation or excess of force applied over the device during the setting up.Consequently, affect the performance of the device.For that reason, the as analyzed cause code will be failure to follow instructions.Therefore, all compiled information on this investigation determines that the most probable cause is failure to follow instructions since problems traced to the user not following the manufacturer's instructions.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18992333
• MDR Text Key: 338809980
• Report Number: 2124215-2024-17234
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K191609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/06/2024

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 Model Number: M006190322090
• Device Catalogue Number: 1983-03
• Device Lot Number: 0031988153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2023
• 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