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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 Perforation of Vessels (2135)
Event Date 04/19/2021
Event Type  Injury  
Manufacturer Narrative
Internal reference: (b)(4). This case was reviewed and investigated according to the manufacturer¿s policy. No information available. The manufacturer's guide wire (phoenix) did not cause or contribute to the perforation. No information available. Not applicable for this device. The implanted or explanted dates are not applicable to this device. Not applicable for this device. Country is (b)(6). The phoenix catheter system was discarded and not returned for evaluation, thus no returned product investigation was performed. 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
It was reported that during a peripheral procedure, the manufacturer's catheter was flushed with normal preparation. The manufacturer's catheter was easily loaded on to a v18 guidewire inside the distal left anterior tibialis with no complications. Then, the v18 guidewire was changed via a quickcross to the manufacturer's guidewire. The manufacturer's catheter was placed into the proximal anterior tibialis and treated two short lesions in the proximal part with two passages. At the end of the second lesion, the manufacturer's catheter had a slight resistance and was taken back. Follow-up angiography images showed a perforation, which was treated twice with a 3 min dilatation with a 2mm/4 cm balloon and a 3mm/8cm amphirion. After treatment, the patient had good result. This adverse event is being submitted because the patient experienced perforation and required intervention.
 
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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
2870 kilgore road
rancho cordova, CA 95670
7863902600
MDR Report Key11742295
MDR Text Key249223944
Report Number2939520-2021-00021
Device Sequence Number1
Product Code MCW
Combination Product (y/n)Y
Reporter Country CodeGM
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 04/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2021
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 Number02262102
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 Manufactured02/13/2021
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: 04/28/2021 Patient Sequence Number: 1
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