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

Model Number	M0061458750
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therfore, the lot expiration and device manufacture dates are unknown.It was reported the device was not used past its expiry.(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 vl ureteral stent was used during a ureter pre-stenting procedure performed in the ureter, on (b)(6) 2021.During a planned stent removal procedure, performed on (b)(6) 2021, there was a difficulty in pushing the wire forward within the stent.As a result de-coiling the stent for removal was difficult.The stent was successfully remove via cystoscope and integrated forceps.Another contour vl ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.The patient's condition was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a contour vl ureteral stent was used during a ureter pre-stenting procedure performed in the ureter, on (b)(6) 2021.During a planned stent removal procedure, performed on (b)(6) 2021, there was a difficulty in pushing the wire forward within the stent.As a result de-coiling the stent for removal was difficult.The stent was successfully remove via cystoscope and integrated forceps.Another contour vl ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.The patient's condition was reported to be stable.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported the device was not used past its expiry.Block h6: medical device problem code a150207 captures the reportable event of stent difficult to remove.Block h10: the returned contour vl ureteral stent was analyzed, and a visual evaluation noted that stent two pigtails were in good condition.The shaft middle section was found kinked.The suture string was not returned with the device.No other issues with the device were noted.The reported complaint was confirmed.According to the product analysis, the physician faced a failure of retraction and advancing with the wire.The catheter was received out of the original pouch and without the stabilizer which is evidence that the device was manipulated.It is the most likely that the shaft middle section kinked was generated due to the handling/manipulation of the device or due to an excess of force applied to the interaction with other devices during the procedure, also, the anatomy of the patient could have contributed to the failure found, affecting the device performance.The kink found in the shaft could have made difficult the advancement of the wire within the stent along and consequently affecting the removal of the stent.The most probable cause of this complaint is adverse event related to procedure since it is the most likely that the adverse event occurred during procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• Brand Name: CONTOUR VL SUREDRIVE
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11979340
• Report Number: 3005099803-2021-02554
• Device Sequence Number: 17010339
• Product Code: FAD
• UDI-Device Identifier: 08714729903307
• UDI-Public: 08714729903307
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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: M0061458750
• Device Catalogue Number: 64442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1