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

Model Number	M0061902230
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a tria firm ureteral stent was used during a procedure in the ureter performed on (b)(6) 2022.During the procedure, it was noted that when the stent was inserted inside the patent and tried to remove the suture, the stent got torn, however, the stent could be pulled by suture and was sucessfully removed from the patient.The procedure was successfully completed using another tria firm ureteral stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device code a0414 captures the reportable event of stent torn, inside the patient.Block h10: the returned tria firm ureteral stent was analyzed, and a visual evaluation noted that the bladder pig tail was detached.Additionally, the suture was returned loaded and cut.Then during magnification observed closely the detached and observed that suture hole was torn.No other problem with the device were noted.The reported event of stent torn was confirmed.Based on the most relevant information of the complaint event description, device analysis and including the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.According to the evidence gathered, it is possible to conclude that operational factors, interaction of the device with the suture string such as an entanglement, manipulation or excess of force applied during it use in the procedure at time to remove the suture, could have caused the detached and torn observed.Consequently, affect the performance of the device.If the suture string or retrieval line is intended to be removed before procedure the line may be removed before stent placement.The retrieval line may be cut prior to stent placement.Remove the retrieval line by holding the knot, cutting one strand, and while holding the knot, gently pull out the retrieval line.According to the time of event, it occurred in the procedure meaning that the suture must have been cut and gently removed, however, the evidence shows the contrary with a stent coil detached and the suture hole torn.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 manufacturers instructions.Block h11: block d4 upn and lot number has been corrected.
Event or Problem Description
It was reported to boston scientific corporation that a tria firm ureteral stent was used during a procedure in the ureter performed on (b)(6) 2022.During the procedure, it was noted that when the stent was inserted inside the patent and tried to remove the suture, the stent got torn, however, the stent could be pulled by suture and was sucessfully removed from the patient.The procedure was successfully completed using another tria firm ureteral stent.There were no patient complications reported as a result of this event.

• Brand Name: TRIA FIRM
• Common Device Name: 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: 15175411
• Report Number: 3005099803-2022-04133
• Device Sequence Number: 15039862
• Product Code: FAD
• UDI-Device Identifier: 08714729937852
• UDI-Public: 08714729937852
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2025
• Device Model Number: M0061902230
• Device Catalogue Number: 1983-01
• Device Lot Number: 0028656961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown