MAUDE Adverse Event Report: PHILIPS VOLCANO PHOENIX CATHETER SYSTEM, 1.8MM X 130CM, 5F (KIT); CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	P18130K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4): the dissection showed no significant extravasation and required no further intervention.Additional information, the wire appeared to be stuck in a sub-intimal plane.The dissection was resolved with no further intervention.Device is not serialized.The implanted or explanted dates are not applicable to this device.Device not returned to manufacturer for analysis.(b)(4).The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.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
It was reported during a planned therapeutic peripheral procedure, the manufacturers device successfully debulked the desired lesion in the left posterior tibial (pt).There was resistance when removing the device, but was removed successfully.An.014 sleek balloon was advanced to the same area and was not able to cross the wire area in question.The wire and balloon were then removed as an assembly, the wire remained in the balloon.The case was completed with patient balloon angioplasty, patient is reportedly in "fine" and "positive" condition.This adverse event is being submitted since the manufactures device was used when the patient experienced a vessel dissection.This is not being reported as a product problem since recurrence of the malfunction would not result in patient harm.
Additional Manufacturer Narrative
Block h6: added code 4755 (part/component/sub-assembly term not applicable) and 4613 (minor injury/illness/impairment).

• Brand Name: PHOENIX CATHETER SYSTEM, 1.8MM X 130CM, 5F (KIT)
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 11642984
• Report Number: 2939520-2021-00013
• Device Sequence Number: 3052648
• Product Code: MCW
• UDI-Device Identifier: 00845225002619
• UDI-Public: (01)00845225002619(17)22103(10)10052009
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K140944
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: P18130K
• Device Catalogue Number: 400-0200.290
• Device Lot Number: 11052002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 06/06/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PHILIPS: 0.014" PHOENIX GUIDE WIRE
• Outcome Attributed to Adverse Event: Other