MAUDE Adverse Event Report: VOLCANO CORP. VERRATA PRESSURE GUIDE WIRE; VOLCANO VERRATA

Model Number 10300J

Device Problems Difficult to Remove (1528); Sticking (1597); Extrusion (2934)

Patient Problem Vascular Dissection (3160)

Event Date 07/10/2014

Event Type  Injury  

Event Description

Patient in for elective cardiac catheterization.During the procedure, a volcano verrata pressure guide wire was inserted without difficulty.When attempting to move the wire into position, the wire became stuck; the physician was unable to pull back or advance the wire.Several maneuvers were attempted before the wire was dislodged.However, in the interim, the artery was dissected.Repair was eventually completed.

• Brand Name: VERRATA PRESSURE GUIDE WIRE
• Type of Device: VOLCANO VERRATA
• Manufacturer (Section D): VOLCANO CORP.; 3721 valley centre dr.; ste 500; san diego CA 92130
• MDR Report Key: 3966522
• MDR Text Key: 4631199
• Report Number: MW5037487
• Device Sequence Number: 1
• Product Code: DXO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2015
• Device Model Number: 10300J
• Device Catalogue Number: 10300J
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/17/2014
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 84