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U.S. Department of Health and Human Services

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

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PHILIPS VOLCANO PHOENIX CATHETER SYSTEM, 1.8MM X 130CM, 5F (KIT) CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
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.
 
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Brand NamePHOENIX CATHETER SYSTEM, 1.8MM X 130CM, 5F (KIT)
Type of DeviceCATHETER, 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 Key11642984
MDR Text Key245924971
Report Number2939520-2021-00013
Device Sequence Number1
Product Code MCW
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K140944
Number of Events Reported123
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 Received04/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberP18130K
Device Catalogue Number400-0200.290
Device Lot Number11052002
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 Received06/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/28/2020
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
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