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

Model Number M006190223090

Device Problems Entrapment of Device (1212); Deformation Due to Compressive Stress (2889); Material Deformation (2976); Material Twisted/Bent (2981)

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

Event Date 10/23/2023

Event Type  malfunction  

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0406 captures the reportable event of stent buckled material, inside the patient.

Event Description

It was reported to boston scientific corporation that a tria firm ureteral stent was used during a urinary tract stone removal surgery procedure to treat urolithiasis in the renal urethra performed on (b)(6).2023.During the procedure, the stent was inserted under fluoroscopy and the guidewire was removed, however, when the stent placement was completed, the guidewire was stuck.Several attempts to remove but it was not successful.The stent and guidewire were pulled out together from the patient.It was noted there was a damaged on the pigtail part of the stent on the bladder side.It was found that there was an accordion problem, and the positioner was flattened when the guidewire was tried to be pulled out.The procedure was successfully completed with another tria firm ureteral stent.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0406 captures the reportable event of stent buckled material, inside the patient.Block h10: the returned tria firm ureteral stent was analyzed, and a magnification, media and visual evaluation noted that the bladder coil was buckled or accordion and the bladder tip was torn.Additionally, the suture and positioner were not returned.During functional inspection, the mandrel 0.039 was loaded into the device and no resistance was felt.No other problems with the device were noted.The reported event of stent buckled material is confirmed, however, the reported event of guide wire stuck, and stent positioner bent are not confirmed, since neither of the devices were returned.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.It is possible to conclude that this problem could be caused by operational factors, interaction of the device between the positioner and the guide wire while the device was pushing up, such as excess of force applied over the device during the procedure could have contributed to the problem, consistently leading to device being buckled or accordion and torn.Consequently, affect the performance of the device.For the reported problem of guide wire stuck and stent positioner bent, since the devices was not returned and could not be analyzed, the as analyzed code for both is going to be no problem detected.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.

Event Description

It was reported to boston scientific corporation that a tria firm ureteral stent was used during a urinary tract stone removal surgery procedure to treat urolithiasis in the renal urethra performed on (b)(6) 2023.During the procedure, the stent was inserted under fluoroscopy and the guidewire was removed, however, when the stent placement was completed, the guidewire was stuck.Several attempts to remove but it was not successful.The stent and guidewire were pulled out together from the patient.It was noted there was a damaged on the pigtail part of the stent on the bladder side.It was found that there was an accordion problem, and the positioner was flattened when the guidewire was tried to be pulled out.The procedure was successfully completed with another tria firm ureteral stent.There were no patient complications reported as a result of this event.

• 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; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 18142289
• MDR Text Key: 328191161
• Report Number: 2124215-2023-63200
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M006190223090
• Device Catalogue Number: 1983-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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