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

Model Number M0061802210

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Information (3190)

Event Date 07/29/2019

Event Type  Injury  

Event Description

During insertion of ureteral stent, when the surgeon was placing the guide wire into the stent, the stent was noted to have a tear.The torn stent was removed and a new stent was placed.Fda safety report id # (b)(4).

• Brand Name: BOSTON SCIENTIFIC
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 8855420
• MDR Text Key: 153360189
• Report Number: MW5088646
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/30/2019

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: M0061802210
• Device Lot Number: 23290399
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 106