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

Model Number	M0061456140
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an ascerta ureteral stent was used during a percutaneous nephrolithonomy procedure in the kidney, performed on (b)(6) 2022.During the procedure, when the scrub technician pulled the guidewire out, the guidewire started to unravel causing the stent to tear.The procedure was completed without a stent implanted.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Block h6: medical device problem code a0414 captures the reportable event of stent torn material inside the patient.Block h10: the returned ascerta ureteral stent was analyzed, and a visual evaluation noted that the stent shaft was detached.The suture was not returned.A functional evaluation could not be performed due to the device was obstructed inside by a piece of guidewire used.Dissection of the unit confirmed that a piece of guidewire was stuck inside the stent.During magnification observed closely that section where the device was detached and observed several torn along the stent.No other malfunction with the device were noted.The reported event was confirmed.According to the product analysis, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.It was possible to conclude that some kind of force at the time to interact with the wire such as the handle/manipulation during the procedure could have caused the device got detached and torn.Moreover, these factors could have contributed to a part of the wire was left inside the device causing that this being obstructed.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.
Event or Problem Description
It was reported to boston scientific corporation that an ascerta ureteral stent was used during a percutaneous nephrolithonomy procedure in the kidney, performed on (b)(6) 2022.During the procedure, when the scrub technician pulled the guidewire out, the guidewire started to unravel causing the stent to tear.The procedure was completed without a stent implanted.There were no patient complications reported as a result of this event.

• Brand Name: ASCERTA
• 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: 15621049
• Report Number: 3005099803-2022-05939
• Device Sequence Number: 5979489
• Product Code: FAD
• UDI-Device Identifier: 08714729802976
• UDI-Public: 08714729802976
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2022

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: 01/31/2024
• Device Model Number: M0061456140
• Device Catalogue Number: 145-614
• Device Lot Number: 0029366128
• 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: 09/22/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2022
• 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 Age: 56 YR
• Patient Sex: Male