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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VOLCANO CORPORATION VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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VOLCANO CORPORATION VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Device Problems Break (1069); Device Inoperable (1663)
Patient Problems Muscle Spasm(s) (1966); ST Segment Elevation (2059)
Event Date 10/30/2017
Event Type  malfunction  
Event Description
Coronary ifr procedure both volcano ifr machines malfunctioned causing wire to be in the coronary artery for extended period of time causing coronary spasm, reduction of blood flow and st elevation.Patient was symptomatic resulting in medical intervention, fluid resuscitation with eventual spontaneous blood flow restoration.The patient recovered to baseline shortly after interventions.Both machines have been removed from service, labeled as broken, supervisor and company representative notified.Manufacturer response: for ifr machine, volcano ifr machine (per site reporter), no response to date.
 
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Brand Name
VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM
Type of Device
SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
VOLCANO CORPORATION
2870 kilgore rd.
rancho cordova CA 95670
MDR Report Key7103976
MDR Text Key94410756
Report Number7103976
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Other Device ID NumberMODEL 5 IMAGING SYSTEM; IFR M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2017
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/02/2017
Event Location Hospital
Date Report to Manufacturer11/02/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
CARDIAC DRUGS
Patient Outcome(s) Other;
Patient Age63 YR
Patient Weight69
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