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

Model Number 88901

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 07/10/2022

Event Type  malfunction  

Event Description

While on stand-by using the volcano, the machine registered "catheter fault" code.We had to open a new catheter off the shelf to complete the case.The representative told us that the visions pv 035 catheter was faulty.Similar reports in maude.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; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 15102625
• MDR Text Key: 296577757
• Report Number: 15102625
• 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: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 88901
• Device Lot Number: 0302590299
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1