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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE

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CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE Back to Search Results
Model Number PRD-SC30-MICRO
Device Problems Entrapment of Device (1212); Unintended System Motion (1430)
Patient Problem Perforation of Vessels (2135)
Event Date 05/15/2020
Event Type  Injury  
Manufacturer Narrative
Analysis of the reported device is in progress. A supplemental report will be submitted when the device analysis is completed. (b)(4).
 
Event Description
The stealth peripheral orbital atherectomy device was selected for treatment of a proximal lesion located in the anterior tibial artery. The vessel was 70% stenosed, and 3mm in diameter. The oad was operated on low speed and jumped forward on the first treatment pass. On the third treatment pass the oad stopped spinning. All expected leds were visibly lit at this time. Repositioning of the oad was attempted, however it was stuck on the guide wire. Glideassist mode was used to remove the oad from the patient's body and the guide wire remained in place. A vessel perforation was observed after the oad was removed. Balloon angioplasty was performed at 8 atmospheres for one minute. Imaging still showed extravasation and a blood pressure cuff was placed below the knee and inflated for one hour. After several hours of monitoring the patient, imaging showed no signs of a perforation and the patient was discharged home.
 
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Brand NameDIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Type of DevicePERIPHERAL ATHERECTOMY DEVICE
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
saint paul, mn
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
saint paul, mn
Manufacturer Contact
brittany leider
1225 old highway 8 nw
saint paul, mn 
2591600
MDR Report Key10139376
MDR Text Key194679591
Report Number3004742232-2020-00154
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190634
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2022
Device Model NumberPRD-SC30-MICRO
Device Catalogue Number7-10059-01
Device Lot Number314836
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/27/2020
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: 06/10/2020 Patient Sequence Number: 1
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