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U.S. Department of Health and Human Services

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

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CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 EXCHANGEABLE SERIES PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE Back to Search Results
Model Number DBP-EX-200SOL145
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 08/20/2021
Event Type  Injury  
Manufacturer Narrative
Estimated age. The patient is in her late 70's to early 80's. The results of the investigation are inconclusive since the reported device was not returned for analysis. Based on the information received, the cause of the reported event could not be conclusively determined. The device history record for the reported oad could not be reviewed as the lot number was not provided. If the lot number is provided, a dhr review will be performed. The physician could not form a medical opinion as to the class/severity of the dissection, though no staining was observed on imaging. It was also reportedly difficult to determine when the dissection occurred since imaging was performed only after angioplasty. Therefore, the physician could not rule out csi as contributory. Because of these unknown factors, csi is reporting this event in good faith. Csi id: (b)(4).
 
Event Description
The diamondback exchangeable series peripheral orbital atherectomy device was used for treatment via right groin access in the internal iliac artery. The vessel was mildly tortuous but was straightened with use of the viperwire guidewire. Low, medium, and high speed treatments were administered for no longer than 25 seconds per treatment. Angioplasty was applied, and imaging was performed. A dissection was seen on imaging, and a stent was deployed to resolve it.
 
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Brand NameDIAMONDBACK 360 EXCHANGEABLE SERIES PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Type of DevicePERIPHERAL ATHERECTOMY DEVICE
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old hwy 8 nw
st. paul MN 55112
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old hwy 8 nw
st. paul MN 55112
Manufacturer Contact
morgan hill
1225 old hwy 8 nw
st. paul, MN 55112
MDR Report Key12481603
MDR Text Key271700305
Report Number3004742232-2021-00319
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
Report Date 09/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDBP-EX-200SOL145
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/16/2021 Patient Sequence Number: 1
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