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

Model Number M0061902220

Device Problems Calcified (1077); Entrapment of Device (1212); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)

Patient Problem Insufficient Information (4580)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a tria firm ureteral stent was implanted during a procedure in the kidney, ureter, bladder, performed on (b)(6) 2021.During a stent removal and replacement procedure, performed on (b)(6) 2021, when the physician attempted to remove the implanted stent, it was noticed that the stent was coiled in the kidney & bladder as visualized on the ct scan.Upon trying to remove the stent, it buckled and coiled upon itself in the mid-ureter, the stent could not be dislodged, straighten and removed.It was assumed that the stent was encrusted due to the guidewire could not pass through the middle of the stent.The patient was admitted to the hospital with the intent of getting percutaneous access to insert a nephrostomy tube.The procedure was cancelled and rescheduled due to this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 12492628
• MDR Text Key: 272155546
• Report Number: 3005099803-2021-04856
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0061902220
• Device Catalogue Number: 1983-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR