MAUDE Adverse Event Report: URESIL, LLC TRU-INCISE VALVULOTOME

Catalog Number TIVK2030

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/17/2014

Event Type  malfunction  

Event Description

Uresil tru-incise valvulotome did not work properly in surgical procedure.When injecting heparinized saline through the catheter to prime for procedure, saline was leaking/spurting through the area where injection site/junction meets catheter.Device moved to back table and not used on pt.

• Brand Name: TRU-INCISE VALVULOTOME
• Type of Device: VALVULOTOME
• Manufacturer (Section D): URESIL, LLC; 5418 w. touhy avenue; skokie IL 60077
• MDR Report Key: 3779531
• MDR Text Key: 16915480
• Report Number: 3779531
• Device Sequence Number: 1
• Product Code: MGZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: TIVK2030
• Device Lot Number: 3G680
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2014
• Patient Sequence Number: 1
• Treatment: INJECTION WITH HEPARINIZED SALINE
• Patient Age: 84 YR
• Patient Weight: 72