MAUDE Adverse Event Report: VOLCANO CORPORATION VISION PV IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number VISION PV .035 IVUS CATHETER

Device Problems Material Separation (1562); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2021

Event Type  malfunction  

Event Description

Tip of ivus catheter came apart exposing the bare wire tip at the very end of the catheter.Unable to advance or pull wire out separately.Able to pull catheter out in one piece with no harm to the patient.Patient in for diagnostic cauterization due to chronic dvt in left femoral vein and left extremity pain.Fda safety report id: (b)(4).

• Brand Name: VISION PV IVUS CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION
• MDR Report Key: 11332884
• MDR Text Key: 232219141
• Report Number: MW5099400
• Device Sequence Number: 1
• Product Code: OBJ
• 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: 02/11/2021

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: VISION PV .035 IVUS CATHETER
• Device Lot Number: 127630
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2021
• 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 Age: 49 YR
• Patient Weight: 109