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U.S. Department of Health and Human Services

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

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PHILIPS VOLCANO PHOENIX CATH SYSTEM, 2.4MM X 127CM, 7F (KIT) CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
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.
 
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Brand NamePHOENIX CATH SYSTEM, 2.4MM X 127CM, 7F (KIT)
Type of DeviceCATHETER, 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 Key11319780
MDR Text Key234441767
Report Number2939520-2021-00007
Device Sequence Number1
Product Code MCW
UDI-Device Identifier00845225002633
UDI-Public(01)00845225002633(17)221130(10)10302004
Combination Product (y/n)Y
Reporter Country CodeGM
PMA/PMN Number
K151145
Number of Events Reported123
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 Received02/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPD24127
Device Catalogue Number400-0200.294
Device Lot Number12102005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2020
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
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