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

Model Number	M0061856310
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a contour injection ureteral stent was implanted during a procedure in the kidney and urinary bladder, performed on (b)(6) 2021.On (b)(6) 2021, the physician attempted to remove the implanted stent but it was noticed that the right stent could only be pulled out to the penile meatus.Gentle force was applied to remove the stent but it could not be removed due to a kink in the proximal portion, thus it was stuck in the proximal ureter.The patient was scheduled to have a cysto ureteroscopy the following day since the operating room was not available.On (b)(6) 2021, a cysto ureteroscopy for stent removal was performed.The physician attempted to pull the ureteral stent again but it was still stuck in proximal ureter.A dividing glidewire was placed through the stent to straighten the stent under fluoroscopic guidance.The stent was removed successfully and easily.No calcification was reported and the no new stent was reported to be implanted.There were no patient complications reported as a result of this event.The patient was sent to pacu after the procedure in stable condition.

• Brand Name: CONTOUR VL INJECTION STENT SET
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11674917
• Report Number: 3005099803-2021-01746
• Device Sequence Number: 11544431
• Product Code: FAD
• UDI-Device Identifier: 08714729340805
• UDI-Public: 08714729340805
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/15/2021

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 Model Number: M0061856310
• Device Catalogue Number: 185-631
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/15/2021
• Patient Sequence Number: 1