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U.S. Department of Health and Human Services

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

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PHILIPS VOLCANO ATHEROMED PHOENIX CATH SYSTEM, 2.4MM X 127CM, 7F (KIT) CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number PD24127K
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Embolism (1829)
Event Date 02/12/2020
Event Type  Injury  
Manufacturer Narrative
Internal reference: (b)(4). This case was reviewed and investigated according to the manufacturer¿s policy. Facility declined to provide patient information. No tests/laboratory data was available. No information was available. Serial number is not applicable to this device. The customer is unable to provide the lot number for the device. With no lot number an expiration date is not available. With no lot number a udi number is not available. The implant or explant dates are not applicable to this device. Device was discarded at the customer site and not returned to manufacturer for analysis. Concomitant medical products: bare wire workhorse; emboshield. Device was discarded at the customer site and not returned to manufacturer for analysis. With no lot a device manufacture date is not available.
 
Event Description
It was reported during a therapeutic atherectomy procedure, after several passes the physician passed a calcified lesion in the left mid-sfa, under fluoroscopy the physician saw an embolic piece in the truncus fibularis. The manufacturer's device was removed. Aspiration of the embolus was not successful. The physician placed a second guidewire to use a filter system distal and caught the embolus. The retrieved material was hard and calcified. This adverse event is being submitted because additional intervention was required to remove an embolus. It is unclear if the manufacturer's device caused or contributed to the embolus. There is no allegation of device malfunction.
 
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Brand NamePHOENIX CATH SYSTEM, 2.4MM X 127CM, 7F (KIT)
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
PHILIPS VOLCANO ATHEROMED
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 Key9772560
MDR Text Key192721335
Report Number2939520-2020-00008
Device Sequence Number1
Product Code MCW
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 Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/01/2005,02/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPD24127K
Device Catalogue Number400-0200.294
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Date Manufacturer Received02/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/29/2020 Patient Sequence Number: 1
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