MAUDE Adverse Event Report: PHILIPS VOLCANO VISIONS PV .014P RX; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 014R

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/14/2022

Event Type  Injury  

Manufacturer Narrative

Lot #, expiration date, serial #, udi #, and device manufacture date are unknown.This case was reviewed and investigated according to the manufacturer¿s policy.The visions pv.014p rx was discarded by the facility, thus no returned product investigation was performed.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

Event Description

It was reported that during a therapeutic peripheral procedure, the visions pv.014p catheter tip broke inside the severely calcified renal artery.Attempts to remove the catheter tip with a snare was unsuccessful; therefore, the tip was retained in the patient.No patient injury reported.This adverse event and product problem is being submitted due to the tip separation.Additional intervention was unsuccessful, thus was retained in the patient.

• Brand Name: VISIONS PV .014P RX
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone &business park; b37; alajuela ; CS
• Manufacturer Contact: danielle bullock ; 3721 valley centre drive #500; san diego, CA 92130
• MDR Report Key: 14659557
• MDR Text Key: 294872779
• Report Number: 3008363989-2022-00051
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 014R
• Device Catalogue Number: 400-0200.297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2022
• Initial Date FDA Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MEDTRONIC: 7F TOURGUIDE INTRODUCER SHEATH; UNK MFG AND SIZE: GUIDE WIRE
• Patient Outcome(s): Required Intervention