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

Model Number	M006180157010
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a020503 captures the reportable event of packaging seal compromised.
Event or Problem Description
It was reported that a contour vl ureteral stent was opened to be used during a ureteroscopy procedure in the urethra for stone management performed on (b)(6) 2023.During preparation, a tear was found in the packaging.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.A photo of the complaint device was provided and showed that the packaging seal was compromised.
Additional Manufacturer Narrative
Block h6: imdrf device code a020503 captures the reportable event of packaging seal compromised.Block h10: the returned contour ureteral stent was analyzed, and a visual and media evaluation noted that the pouches were found open almost completely, however, they have evidence of the seal.No other problems with the device were noted.The four photos attached show one contour stent out of the original pouch.There is no evidence of seal compromised.Additionally, the suture and positioner did not return, the contour was returned, and no damages were observed.The reported event of packaging seal compromised was not confirmed.Taking all available information into consideration, most likely, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.It is possible to conclude that the pouches were manipulated since they were found open almost completely, and they had evidence of the seal.This product has inspections and controls to prevent this type of problem.Therefore, the conclusion code for the reported complaint will be no problem detected since after visual inspection it was not possible to identify any evidence of the alleged issue.
Event or Problem Description
It was reported that a contour vl ureteral stent was opened to be used during a ureteroscopy procedure in the urethra for stone management performed on (b)(6) 2023.During preparation, a tear was found in the packaging.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.A photo of the complaint device was provided and showed that the packaging seal was compromised.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 18028224
• Report Number: 3005099803-2023-05704
• Device Sequence Number: 20311776
• Product Code: FAD
• UDI-Device Identifier: 08714729058434
• UDI-Public: 08714729058434
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 01/03/2024

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: 05/11/2025
• Device Model Number: M006180157010
• Device Catalogue Number: 180-157-01
• Device Lot Number: 0027409588
• 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: 10/05/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2021
• 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