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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 Problems Vessel Or Plaque, Device Embedded In (1204); Muscle Spasm(s) (1966)
Event Date 11/12/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). This case was reviewed and investigated according to the manufacturer¿s 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. Additional information obtained indicated manufacturers catheter device performed as intended. This was the second pass, at the end of the procedure, the wire was brand new. The patient had significant spasm as the manufacturers device was being removed and the wire malfunctioned. Vessel was ballooned but the distal end of the wire remained in the dorsalis pedis. Once wire was removed it was apparent the wire had sheared off in the lumen of the artery. There was no obvious damage to the manufacturers device. The patient was sent to the hospital and a focal open procedure was performed the following day to remove the wire from the dorsalis pedis. The patient was discharged and is reportedly ambulatory and in good spirits. No information available. The implant or explant dates are not applicable to this device. Recall: not applicable for this device. Concomitant medical products: phoenix guide wire, 11cm cordis access sheath. Device not returned to manufacturer for analysis. The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.
 
Event Description
It was reported during a planned therapeutic peripheral procedure, another manufacturer's wire device broke off in the patient. The tip was retrieved one day after the case.
 
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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)
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 Key10901162
MDR Text Key218198734
Report Number2939520-2020-00036
Device Sequence Number1
Product Code MCW
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K140944
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2021
Device Model NumberP18130K
Device Catalogue Number400-0200.290
Device Lot Number10281908
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/09/2019
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: 11/25/2020 Patient Sequence Number: 1
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