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

Model Number	PD22130K
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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)
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 11346812
• Report Number: 2939520-2021-00009
• Device Sequence Number: 11622973
• Product Code: MCW
• UDI-Device Identifier: 00845225002985
• UDI-Public: (01)00845225002985(17)231031(10)10232005
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K140944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2021

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1