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

Model Number M0061802310

Device Problems Unsealed Device Packaging (1444); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a contour ureteral stent was attempted to be used during a ureteroscopy procedure in the ureter, performed on (b)(6) 2022.During unpacking, it was found that the sterile package of the device was not sealed.Another contour ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.

• Brand Name: CONTOUR
• Type of Device: 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: 13560600
• MDR Text Key: 289187272
• Report Number: 3005099803-2022-00752
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729058656
• UDI-Public: 08714729058656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/18/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2024
• Device Model Number: M0061802310
• Device Catalogue Number: 180-231
• Device Lot Number: 0027003235
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1