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

Model Number	M0061801560
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter state: sg medical problem code a0406 captures for the reportable investigation results of stent buckled inside the patient.The returned contour vl ureteral stent was analyzed, and a visual evaluation noted that the bladder pig tail accordion and drag marks beside the tip.The suture string and the stabilizer did not return, only the positioner returned in a good shape.A functional assessment was performed, the mandrel 0.035" was inserted through the catheter and no resistance was felt and the mandrel was unloaded without issues.No other problems with the device were noted.The reported event was confirmed.Based on the product analysis, the device found with the bladder pig tail accordion and drag marks beside the tip.It is possible that operational factors, such as the force used when the stent was pushed up with the pusher or positioner over the guidewire or when the stent was used, excess of force applied that could cause the found problems.Therefore, the investigation concluded that adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a contour vl ureteral stent was used during a retrograde intrarenal surgery procedure in the kidney, ureter, and bladder performed on (b)(6) 2021.During the procedure, it was noted that they could not deploy the contour vl ureteral stent inside the patient.It was found that the stent gripped into the guidewire.The procedure was successfully completed with another contour vl ureteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Investigation results revealed that the stent buckled inside the patient, therefore this event has been deemed an mdr reportable event.

• Brand Name: CONTOUR VL
• 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: 13653701
• Report Number: 3005099803-2022-00856
• Device Sequence Number: 5750231
• Product Code: FAD
• UDI-Device Identifier: 08714729067986
• UDI-Public: 08714729067986
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2022

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: 08/30/2024
• Device Model Number: M0061801560
• Device Catalogue Number: 180-156
• Device Lot Number: 0027921247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• 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 Sex: Unknown