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

Model Number M006190372090

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/29/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a tria soft ureteral stent was successfully removed during a stent removal procedure in the ureter tract performed on (b)(6), 2023.During the withdrawal, it was noted that the guidewire was unable to cross and the pigtail on the renal side became a fish-hook shape, therefore, they had difficulty removing the stent.The procedure was successfully completed with the original device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Initial reporter city: (b)(6).Imdrf device code a0406 captures the reportable event of stent material deformation, inside the patient.Imdrf device code a150207 captures the reportable event of stent difficult to remove.

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 e1: initial reporter city: (b)(6).Block h6: imdrf device code (b)(6) captures the reportable event of stent material deformation, inside the patient.Imdrf device code (b)(6) captures the reportable event of stent difficult to remove.Block h10: the reported event was not confirmed.Based on the most relevant information, the device met all manufacturing specifications required and passed all the controls and inspections and no abnormalities were reported during the assembly process.After the analysis, it was found that the stent was with its shaft detached and the suture and the detached part was not returned.Therefore, it was possible to conclude that some operational factors, interaction with an excess force during interaction with the guidewire and or the suture string such as an entanglement of it during their use could have caused the detachment that was observed.Consequently, affecting the performance of the device.Therefore, for that reason, adverse event related to procedure was selected for this complaint.The reported events of "stent.Difficult to remove", "stent.Material deformation" and "device.Guidewire stuck" were not confirmed due to not receiving a complete device return.Additionally, analysis of the returned portion of the stent did not identify a related issue with the reported allegations.Therefore, no problem detected was selected as the most probable root cause for the complaint because the reported events could not be confirmed.

Event Description

It was reported to boston scientific corporation that a tria soft ureteral stent was successfully removed during a stent removal procedure in the ureter tract performed on (b)(6) 2023.During the withdrawal, it was noted that the guidewire was unable to cross and the pigtail on the renal side became a fish-hook shape, therefore, they had difficulty removing the stent.The procedure was successfully completed with the original device.There were no patient complications reported as a result of this event.

• 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: 16779962
• MDR Text Key: 313828521
• Report Number: 3005099803-2023-02024
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

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: M006190372090
• Device Catalogue Number: 1983-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 06/14/2023
• 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