MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTOUR VL SOFT PERCULFEX 4.8X22; STENT, URETERAL

Model Number M0061801550

Device Problems Difficult to Insert (1316); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2023

Event Type  Injury  

Event Description

Bladder end of device defective and unable to insert for use.

• Brand Name: CONTOUR VL SOFT PERCULFEX 4.8X22
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 2546 first st; propark el coyol alajuela, cr
• MDR Report Key: 16700957
• MDR Text Key: 313005899
• Report Number: MW5116430
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0061801550
• Device Lot Number: 30888975
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 108 KG
• Patient Ethnicity: Non Hispanic