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

Model Number M006190321090

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a1802 captures the reportable event of packaging foreign matter.

Event Description

It was reported to boston scientific corporation that a tria soft ureteral stent was used during a ureteral stent placement procedure in the ureter performed on (b)(6) 2024.During the procedure, a foreign material contamination was found.It was noted that the foreign material was inside the sterile packaging.The procedure was successfully completed with another tria soft ureteral stent.There were no patient complications reported as a result of this event.A photo of the complaint device was provided and showed that the sterility packaging was compromised.

Manufacturer Narrative

Initial reporter fax imdrf device code a1802 captures the reportable event of packaging foreign matter.The returned tria ureteral stent was analyzed, and a visual evaluation noted that the box was returned and the open pouch of an open-end ureteral access catheter with a foreign matter attached with a tape located in the label.No other problems with the device were noted.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.Therefore, the investigation will be documented as manufacturing deficiency due to problems traced to manufacturing process.

Event Description

It was reported to boston scientific corporation that a tria soft ureteral stent was used during a ureteral stent placement procedure in the ureter performed on (b)(6) 2024.During the procedure, a foreign material contamination was found.It was noted that the foreign material was inside the sterile packaging.The procedure was successfully completed with another tria soft ureteral stent.There were no patient complications reported as a result of this event.A photo of the complaint device was provided and showed that the sterility packaging was compromised.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19012081
• MDR Text Key: 339022063
• Report Number: 2124215-2024-19198
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2024

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: M006190321090
• Device Catalogue Number: 1983-03
• Device Lot Number: 0031779655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2023
• 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