MAUDE Adverse Event Report: PHILIPS VOLCANO PHOENIX CATH SYSTEM, 2.4MM X 127CM, 7F (KIT) CATHETER, PERIPHERAL, ATHERECTOMY

Model Number PD24127

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

Patient Problem Vascular Dissection (3160)

Event Date 02/03/2021

Event Type  Injury  

Manufacturer Narrative

Internal reference: (b)(4). This case was reviewed and investigated according to the manufacturer¿s policy. Attempts to obtain patient information are unsuccessful. Attempts to obtain patient information were made via email. All reasonably known patient information is included in this report. Device is not serialized. The implant or explant dates are not applicable to this device. Device not returned to manufacturer for analysis. 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 manufacturer¿s policy. It was reported during a therapeutic peripheral procedure, the physician was performing an atherectomy of two lesions in the right sfa and popliteal. During the second passage of the distal lesion the handle stopped twice. The physician reconnected the handle and we could proceed the 2nd passage of the distal popliteal lesion. The control angiography showed than a dissection in the popliteal segment and a leak of contrast media. The physician decided to make a prolonged dilatation with another manufacturers balloon device over 10 minutes with outside pressure from a blood pressure cuff. Control showed a good result with no leaks of contrast media. The physician treated the proximal lesion with an another manufacturers angioplasty balloon. The physician checked the leg from proximal up to the foot. In consultation with the vascular surgeon the decision was to keep it without stenting. Patient was fine all the time, no pain, no issues. This adverse event is being submitted because the manufactures device was used in a procedure where the patient experienced a vessel dissection.

• Brand Name: PHOENIX CATH SYSTEM, 2.4MM X 127CM, 7F (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: 11319780
• MDR Text Key: 234441767
• Report Number: 2939520-2021-00007
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00845225002633
• UDI-Public: (01)00845225002633(17)221130(10)10302004
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K151145
• 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,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 11/30/2022
• Device Model Number: PD24127
• Device Catalogue Number: 400-0200.294
• Device Lot Number: 12102005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2020
• 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: 02/11/2021 Patient Sequence Number: 1