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

Model Number	M0061902220
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a tria firm ureteral stent was used during an unspecified procedure on (b)(6) 2022.During the withdrawal/closure of the procedure, the coil of the stent detached.The detached coil was removed via grasping forceps under rigid ureteroscopy.The procedure was completed with another tria firm ureteral stent.There was no patient injury or complication as a result of the event.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported, to boston scientific corporation.That a tria firm ureteral stent was used, during an unspecified procedure on (b)(6) 2022.During the withdrawal/closure of the procedure, the coil of the stent detached.The detached coil was removed via grasping forceps under rigid ureteroscopy.The procedure was completed with another tria firm ureteral stent.There was no patient injury or complication as a result of the event.
Additional Manufacturer Narrative
Block h6: device code a0501, is being used to capture the reportable event of coil detachment of device or device component.Impact code f2301, captures the reportable event of additional device required.Block h10: the returned tria ureteral stent was analyzed, and a visual evaluation noted, that there was a detachment in the bladder pigtail.Their respective positioner was returned.However, no problems noted.The suture was returned loaded and cut.A functional inspection was performed, a mandrel of 0,039 passed through the stent without resistance.No other problems with the device were noted.The reported event was confirmed.Analysis of the returned device found with their bladder coil detached, suture hole, bladder coil tip was torn, and the suture was cut, indicating that there was a manipulation of the device.These problems could be caused by operational factors, interaction of the device with entangled suture string after the insertion.Also, it is possible, that an excess of force applied to the suture string, during procedure could have been damaged and caused this problem.Consequently, affect the performance of the device.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.Block h11: correction to block b1: (adverse event/product problem), block d4: (model number), block e1: (initial reporter city), block e1: (initial reporter fax), block h1: (type of reportable event), and block h10: (impact code).

• 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: 15681830
• Report Number: 3005099803-2022-06266
• Device Sequence Number: 6336808
• Product Code: FAD
• UDI-Device Identifier: 08714729937845
• UDI-Public: 08714729937845
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2025
• Device Model Number: M0061902220
• Device Catalogue Number: 1983-01
• Device Lot Number: 0028839339
• 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: 10/05/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown