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

Model Number M0061801560

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

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

Event Date 03/22/2024

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a contour vl ureteral stent was used during a stent insertion procedure performed on (b)(6) 2024.During the procedure, when the physician attempted to remove the sensor wire for stent placement, the sensor wire was stuck onto the stent.The stent became shredded, and the wire uncoiled itself.The guidewire and stent were removed from the patient without a problem.Another stent and guidewire completed the procedure.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h6: imdrf device code a0414 captures the reportable event of stent torn.

• Brand Name: CONTOUR VL
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19134820
• MDR Text Key: 340832649
• Report Number: 2124215-2024-22571
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729067986
• UDI-Public: 08714729067986
• 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
• Report Date: 04/18/2024

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 Model Number: M0061801560
• Device Catalogue Number: 180-156
• Device Lot Number: 0032630059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2023
• 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