MAUDE Adverse Event Report: PHILIPS IMAGE GUIDED THERAPY CORPORATION VISIONS PV .035 DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 88901

Device Problems Poor Quality Image (1408); Device Displays Incorrect Message (2591)

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

Event Date 09/13/2022

Event Type  malfunction  

Event Description

After placement into the patient, the ivus catheter failed (poor image quality) and displayed an error code.The catheter was replaced with another ivus catheter with the same result.A third ivus catheter was opened and worked as expected.There was no harm to the patient.Manufacturer response for catheter, volcano visions pv.035 (per site reporter) product handled by site.

• Brand Name: VISIONS PV .035 DIGITAL IVUS CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS IMAGE GUIDED THERAPY CORPORATION; 5905 nathan lane north; plymouth MN 55442
• MDR Report Key: 15492120
• MDR Text Key: 300644113
• Report Number: 15492120
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 88901
• Device Lot Number: 0302692744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1