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

Model Number M0061802230

Device Problems Failure to Advance (2524); Material Split, Cut or Torn (4008)

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

Event Date 09/08/2021

Event Type  malfunction  

Event Description

Upon opening new 6x26 boston scientific stent, it was noted by doctor that there was a slit along the length of stent where the curl is, making it unable to be passed.Luckily it was noted before it was attempted to be inserted into patient.

• Brand Name: CONTOUR
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12525454
• MDR Text Key: 273110340
• Report Number: 12525454
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729058533
• UDI-Public: (01)08714729058533
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/08/2021

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
• Device Operator: Health Professional
• Device Model Number: M0061802230
• Device Lot Number: 27572999
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA