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

Model Number	M0061801550
Medical Device Problem Codes	Contamination (1120); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned contour vl ureteral stent was analyzed, and a visual evaluation noted that the bladder pigtail was buckled/accordioned and the pigtail tip was damaged and kinked.Functional inspection noted that it was not possible to pass the wire through the device because the stent had an obstruction inside, located approximately at the sixth hold from the tip, at the distal section.The contour vl ureteral stent was cleaned by pushing the mandrel 0.035 through and after the obstruction came out no resistance was felt.Due to the characteristics of the obstruction it is possible that it was dry blood or some organic residues that got in the ureteral stent when trying to implant the stent as it was not fully implanted, but it was unable to be confirmed what the obstruction was.No other issues with the device were noted.The reported event was confirmed.Based on the product analysis, the problem found stent buckled/accordioned at the bladder pigtail section is known to be generated due to the force used when the stent was pushed up with the pusher/positioner over the guidewire or when the stent was used.Additionally, the device had an obstruction, foreign material, in the stent and the wire could not pass through the device and also the bladder pigtail tip was damaged.Moreover, the device was received without the suture string, evidence that the device was manipulated; therefore, it is the most likely that the problems found were generated due to the manipulation of the device or due to the interaction with other devices during the procedure.It's important to mention that during product analysis the device was tested and mandrel 0.035" were inserted through the catheter and an obstruction, foreign material, was found, the device was cleaned and the mandrel passed without any issue.Review and analysis of all available information indicated that the root cause is adverse event related to procedure.A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during the procedure and the device had no influence on the event.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 an unknown procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the contour vl ureteral stent was tortuous at one extremity.The procedure was completed with another of the same device.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.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.This event has been deemed a reportable event based on the investigation finding of foreign material present in the contour vl ureteral stent.

• Brand Name: CONTOUR VL
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11328003
• Report Number: 3005099803-2021-00536
• Device Sequence Number: 11041603
• Product Code: FAD
• UDI-Device Identifier: 08714729058410
• UDI-Public: 08714729058410
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/15/2021

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 Expiration Date: 01/27/2022
• Device Model Number: M0061801550
• Device Catalogue Number: 180-155
• Device Lot Number: 0023256677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR