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

Model Number	M0061802210
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
As staff was opening stent to put on sterile table, stent broke and was removed.Operating room staff was opening stent to put on sterile field.Stent did not touch patient.

• Brand Name: CONTOUR¿
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7776834
• Report Number: 7776834
• Device Sequence Number: 13901665
• Product Code: FAD
• UDI-Device Identifier: 08714729058472
• UDI-Public: (01)08714729058472
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2018
• Report Date (Section F): 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: M0061802210
• Device Lot Number: 21279856
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 08/13/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 118
• Date Report Sent to FDA: 07/30/2018