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

Model Number M006190232090

Device Problems Calcified (1077); Obstruction of Flow (2423)

Patient Problem Urinary Tract Infection (2120)

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported the device was not used past its expiry.Initial reporter state: (b)(6).(b)(4).The returned tria ureteral stent was analyzed, and a visual evaluation noted that calcification residues were found along of the proximal and distal section, bladder and renal pigtail, additionally, the device is occluded due the calcification presence in the device in the tip.No other issues with the device were noted.The reported event was confirmed.According to product analysis, the device was calcified at distal and proximal sections, the device was occluded due to the calcification present in the stent.Based on the information available, this condition will affect the device performance.Therefore, known inherent risk of device is selected as the most probable root cause for the complaint.A complaint with a cause of known inherent risk of device indicates that the adverse event is known and documented in the labeling, including both short term or long term known complications or adverse reactions.A review of the manufacturing documentation for this device was unable to be performed as lot number is unknown.However, a ship history review was performed to identify the most probable lots and a manufacturing review of the most probable lots did not identify any anomalies or deviations that could have contributed to the event.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

Note: this report is one of two tria ureteral stent complaints that pertain to the same event (mfr report # 3005099803-2020-04692.It was reported that two tria ureteral stent were used during a stent placement procedure in the ureter performed on (b)(6) 2020.According to the complainant, a planned stent removal was performed on (b)(6) 2020.When the physician attempted to explant the stents, it was noticed that the stents had stones/calculus adhering to the lumen and were clogged in the lumen.The stents were still able to drain.Both stents were removed entirely with a pair of forceps and an endoscope.Another tria ureteral stent was implanted and successfully completed the procedure.The patient was noted to have low activities of daily living (adl) and urinary infection.There was no treatment reported for the urinary infection.There were no additional 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10703991
• MDR Text Key: 212143453
• Report Number: 3005099803-2020-04700
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M006190232090
• Device Catalogue Number: 1983-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2020
• 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