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

Device Problems Calcified (1077); Migration (4003)

Patient Problem Pain (1994)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a previously implanted tria ureteral stent was removed during a left percutaneous nephrolithotomy (l pcnl), cystoscopy with retrograde pyelogram, ureter stent placement, cystolitholapaxy procedure performed sometime in 2022.It was repoorted that a 6f double j tria ureteral stent was placed for about 6 months.Post procedure, it was reported that the stent was encrusted and mispositioned.

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of january 1, 2022, was chosen as the best estimate based on the procedure which happened sometime in 2022.Blocks 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 a040501 captures the reportable event of stent calcified.Imdrf device code a010402 captures the reportable event of stent migration.Imdrf impact code f2301 captures the reportable event of additional device required.

• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; st. paul, MN 55112
• MDR Report Key: 19096918
• MDR Text Key: 340031454
• Report Number: 2124215-2024-21789
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2024

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: 03/15/2024
• Initial Date FDA Received: 04/12/2024
• 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: 49 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic