MAUDE Adverse Event Report: C.R. BARD BARD INLAY URETERAL STENT

Catalog Number 778724

Device Problems Kinked (1339); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2017

Event Type  Injury  

Event Description

Bard inlay ureteral stent was placed in the operating room on (b)(6) 2017.Dr.(b)(6) attempted to remove the stent at bedside on (b)(6) 2017 and was unable to remove the stent.A kub was ordered and found the stent to be kinked in the ureter.

• Brand Name: BARD INLAY URETERAL STENT
• Type of Device: BARD INLAY URETERAL STENT
• Manufacturer (Section D): C.R. BARD; covington GA 30014
• MDR Report Key: 7120612
• MDR Text Key: 95059502
• Report Number: MW5073973
• 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: Other
• Type of Report: Initial
• Report Date: 12/13/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 778724
• Device Lot Number: NGBW3823
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2017
• 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: 75 YR
• Patient Weight: 138