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

Model Number	M006180155010
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a contour vl ureteral stent was used during a removal of kidney stones procedure in the right kidney performed on (b)(6) 2022.During the procedure, when the stent was introduced and passed through the urethra and entered the forced of two centimeters into the ureter, and when the stent was pushed, it became buckled and would not advance into the ureter and a torn was observed on the distal part.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.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a contour vl ureteral stent was used during a removal of kidney stones procedure in the right kidney performed on (b)(6) 2022.During the procedure, when the stent was introduced and passed through the urethra and entered the forced of two centimeters into the ureter, and when the stent was pushed, it became buckled and would not advance into the ureter and a torn was observed on the distal part.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.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: medical device code a040601 captures the reportable event of stent buckled, inside the patient.Medical device code a0414 captures the reportable event of stent torn, inside the patient.Block h10: the returned contour vl ureteral stent was analyzed, and a visual evaluation noted that with three unopened pouches, the positioner, guide wire and axxcess catheter.Their stabilizer was also returned in good conditions.Then found that the bladder pig tail was buckled accordion, side port holes stretch out, suture hole and bladder coil tip torn.Additionally, their suture was not returned.No other problem with the device were noted.The reported event was confirmed.Based on the most relevant information of the complaint event description, device analysis and including the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.It was found that the device has the bladder coil buckled or accordion.Also, during magnification, it was found that side port holes were stretched, their suture hole and tip torn.Additionally, the suture was not returned, which means that it was removed, indicating that the stent was used.According to the evidence, it is possible that operational factors, such as interacting of the device with positioner, interaction with another device could cause the buckled or accordion and the holes got stretch and the tip torn.This issue could at the same time cause that the device being difficult to advance in anatomy, consequently, affect the performance of the device.Additionally, an interaction of the device with their suture such as an entanglement could have contributed to the suture hole torn.Therefore, 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 the procedure and the device had no influence on 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: 14955455
• Report Number: 3005099803-2022-03676
• Device Sequence Number: 6914925
• Product Code: FAD
• UDI-Device Identifier: 08714729058427
• UDI-Public: 08714729058427
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• 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,Followup
• Report Date (Section B): 11/04/2022

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: 09/19/2025
• Device Model Number: M006180155010
• Device Catalogue Number: 180-155-01
• Device Lot Number: 0028359899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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 Age: 32 YR
• Patient Sex: Male
• Patient Weight: 84 KG