MAUDE Adverse Event Report: PHILIPS VOLCANO PHOENIX DEFLECT SYSTEM, 2.2MM X 130CM, 6F (KIT); CATHETER, PERIPHERAL, ATHERECTOMY

Model Number PD22130K

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Attempts to obtain patient information have been unsuccessful.Does not apply to this submission.Serial number is not applicable to this device.The implant or explant dates are not applicable to this device.Not applicable for this device.Device was discarded at the customer site and not returned to manufacturer for analysis.Device was discarded at the customer site and not returned to manufacturer for analysis.Do not apply to this submission.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 the alleged death or deterioration in the state of the health of any person.

Event Description

This case was reviewed and investigated according to the manufacturers policy.It was reported after a planned therapeutic peripheral procedure, the shaft of the device appeared to have a formed a small rip (fracture), allowing fluid to escape.The device was removed from the body over the wire, after the device seemed to bind up and stop working.Additional information provided, the device had been inserted into the patient once.There were no issues being removed.The device was re-flushed after removal and saline/blood was being ejected from the shaft of the device.Nothing appeared to be protruding.A second of the same device was used to complete the procedure.The device was discarded at the facility and not returned for analysis.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.This product problem is being submitted in an abundance of caution as it could not be determined where or when the alleged separation occurred.There is a potential for harm if the alleged separation were to recur.

• Brand Name: PHOENIX DEFLECT SYSTEM, 2.2MM X 130CM, 6F (KIT)
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer (Section G): VOLCANO ATHEROMED, INC.; 1530 o brien drive, suite a; menlo park CA 94025
• Manufacturer Contact: melissa mangum ; 2870 kilgore road; rancho cordova, CA 95670 ; 8584650468
• MDR Report Key: 11346812
• MDR Text Key: 242752674
• Report Number: 2939520-2021-00009
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00845225002985
• UDI-Public: (01)00845225002985(17)231031(10)10232005
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K140944
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: PD22130K
• Device Catalogue Number: 300002517361
• Device Lot Number: 12022005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2020
• 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