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

Model Number 014R

Device Problems Material Separation (1562); Material Protrusion/Extrusion (2979)

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

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.No information available.No information available.Not applicable for this device.Not applicable for this device.The visions pv.014p rx was visually and microscopically inspected.The device was separated in two parts and a portion of distal shaft, scanner body, and distal tip were stuck on the guide wire and could not be removed.In addition, the core wire was exposed, resulting in a sharp edge of non malleable material.The probable cause of the reported failure is damage in use as evidence by the device separation.Strain, impact, and forces associated with use can affect the integrity of the device.Do not apply to this submission.

Event Description

It was reported that during a peripheral procedure during pullback, resistance was noted and the manufacturer's catheter got stuck on the non-manufacturer's's guide wire, thus were removed as a unit.Upon removal, there appeared to be a kink and the catheter separated in two pieces at the rapid exchange port, but still attached to the guide wire as it was exiting the body.Imaging was used to ensure there were no other pieces of the catheter or guide wire left in the patient.The procedure was completed with the suspect catheter.No patient injury reported, the patient was discharged with no complications.This product problem is being submitted because a shaft separation and exposed core wire has a potential for harm if the malfunction were to recur.

• Brand Name: VISIONS PV .014P RX
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone & business par; b37; alajuela ; CS
• Manufacturer Contact: ana tan ; 2870 kilgore road; rancho cordova, CA 95670
• MDR Report Key: 11979944
• MDR Text Key: 255983701
• Report Number: 2939520-2021-00039
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(11)210129(17)230129(10)0302152074
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K152829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/11/2021

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 Expiration Date: 01/29/2023
• Device Model Number: 014R
• Device Catalogue Number: 400-0200.297
• Device Lot Number: 0302152074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 06/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2021
• 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