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U.S. Department of Health and Human Services

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

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CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE Back to Search Results
Model Number DBP-200SOLID145
Device Problem Entrapment of Device (1212)
Patient Problems Tissue Damage (2104); Vascular System (Circulation), Impaired (2572); Vascular Dissection (3160)
Event Date 05/21/2020
Event Type  Injury  
Manufacturer Narrative
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 was unable to be reviewed, as the lot number was not provided. If the lot number is provided, a dhr review will be performed. Csi id: (b)(6).
 
Event Description
A diamondback peripheral orbital atherectomy device (oad) was selected for treatment of a lesion in the right distal superior femoral artery (sfa). The lesion was 80 to 90% stenosed, 40-50mm in length, and was mildly to moderately calcified. Access was obtained in the left common femoral artery, and the reference vessel was about 6mm in diameter. Two treatments were administered on low, medium, and high speed. The user noted a dull sound while spinning, but the device was deemed safe for continued use. Following treatment, the oad could not be removed through the 6fr sheath. Imaging was performed, and haziness was noted around the device. A large flow-limiting dissection was identified at the level of the lesion. A second wire was inserted to maintain position, and the oad, guide wire, and sheath were removed together. A new 6fr sheath was inserted, and a stent was deployed to resolve the dissection. Angiography showed the stent had covered the dissection. Brisk, timi 3 flow was noted in the right sfa and runoff vessels. Angiography was then performed for the left common femoral access site, and a large hazy image was noted at the bifurcation of the left sfa and profunda. The physician hypothesized that the hazy image was tissue which may have come off during removal of the oad. Surgical cut down was performed, and large pieces of tissue were removed. Brisk flow was reestablished to the left leg. The following day, the patient was well with bounding pulses in both legs and was expected to be discharged home.
 
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Brand NameDIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Type of DevicePERIPHERAL ATHERECTOMY DEVICE
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old hwy 8 nw
st. paul, mn
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old hwy 8 nw
st. paul, mn
Manufacturer Contact
morgan hill
1225 old hwy 8 nw
st. paul, mn 
MDR Report Key10174468
MDR Text Key195904741
Report Number3004742232-2020-00171
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,Followup
Report Date 07/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDBP-200SOLID145
Device Catalogue Number7-10057-04
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 Received06/26/2020
Was Device Evaluated by Manufacturer? Yes
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: 06/19/2020 Patient Sequence Number: 1
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