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

Device Problems Use of Device Problem (1670); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

Block b3: date of event was approximated to (b)(6) 2023, based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a010402 captures the reportable event of stent migration.

Event Description

It was reported to boston scientific that a tria firm ureteral stent was used during a ureteral stent implantation procedure in the ureter performed on an unknown date.During the procedure, a pusher inserted into the ureter.It was noted that the pusher was connected in the wrong direction and the marker was not checked.As a result, the fluoroscopic imaging showed that the entire tria stent had been pushed into the renal pelvis and wrapped around the urethra.The procedure was successfully completed with another tria firm ureteral stent and the original stent remained in the renal pelvis.The patient's family was informed about the situation, and four days later, the tria ureteral stent was removed from the renal pelvis under general anesthesia.

• Brand Name: TRIA FIRM URETERAL STENT SETS
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17347030
• MDR Text Key: 319377998
• Report Number: 3005099803-2023-03772
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Sex: Male