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

Model Number M0061456140

Device Problems Device-Device Incompatibility (2919); Material Split, Cut or Torn (4008)

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

Event Date 08/26/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

(b)(4).

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 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
• 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: 15621049
• MDR Text Key: 301919865
• Report Number: 3005099803-2022-05939
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729802976
• UDI-Public: 08714729802976
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 11/23/2022
• Supplement Dates FDA Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2022
• 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
• Patient Age: 56 YR
• Patient Sex: Male