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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 PD24127K
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Embolism (1829); Muscle Spasm(s) (1966)
Event Date 01/05/2021
Event Type  Injury  
Manufacturer Narrative
Internal reference: (b)(4). This case was reviewed and investigated according to the manufacturers policy. Attempts to obtain patient information are unsuccessful. Attempts to obtain the 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. Concomitant medical products: phoenix guidewire device not returned to manufacturer for analysis. Recall & correctional/removal number: do not apply to this submission. The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.
 
Event Description
There is no allegation the manufacturers device malfunctioned. It was reported during a planned therapeutic peripheral procedure, the manufacturers device successfully debulked the desired lesion. Resistance was experienced, the manufacturers atherectomy device and another manufacturers guidewire device were removed together. The manufacturers device was discarded. After removal of the devices x-ray showed the tip of the guidewire remained in the superficial femoral artery (sfa). The tip was removed with a microsnare. During tip retrieval a distal embolization occurred and was treated with an aspiration catheter and nitroglycerin. The patient was reported as "fine" at the end of the procedure. Final angiography indicated the lesion was well treated and distal blood circulation was "fine". Lesion: calcified lesion from the proximal sfa up to the p2 segment. This adverse event is being submitted because the manufactures device is a concomitant device in use when another manufactures device separated in a patient. There is no allegation the manufacturers device malfunctioned.
 
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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 Key11155154
MDR Text Key226539606
Report Number2939520-2021-00002
Device Sequence Number1
Product Code MCW
Combination Product (y/n)Y
Reporter Country CodeGM
PMA/PMN Number
K151145
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPD24127K
Device Catalogue Number400-0200.294
Device Lot Number08132001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/23/2020
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: 01/12/2021 Patient Sequence Number: 1
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