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

Model Number P18130K

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 12/03/2020

Event Type  Injury  

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 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.

• Brand Name: PHOENIX CATHETER SYSTEM, 1.8MM X 130CM, 5F (KIT)
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone & business park; b37; alajuela ; CS
• Manufacturer Contact: 2870 kilgore road; rancho cordova, CA 95670 ; 7863902600
• MDR Report Key: 11642984
• MDR Text Key: 245924971
• Report Number: 2939520-2021-00013
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K140944
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: P18130K
• Device Catalogue Number: 400-0200.290
• Device Lot Number: 11052002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 06/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/09/2021 Patient Sequence Number: 1