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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 DBP-125MICRO145
Device Problems Appropriate Term/Code Not Available (3191); Noise, Audible (3273)
Patient Problem Vascular Dissection (3160)
Event Date 11/18/2019
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. The diamondback peripheral orbital atherectomy device instructions for use states that dissection is a possible adverse event which can occur with use of the diamondback peripheral orbital atherectomy device. (b)(4).
 
Event Description
During a procedure with a diamondback peripheral orbital atherectomy device (oad), a dissection occurred. The 100% occluded, heavily calcified, 120mm long target lesion was located in an area of the right peroneal artery that was 4mm in diameter. The lesion was crossed with aggressive non-csi guide wires, and the guide wire was exchanged for a csi viperwire guide wire. It was confirmed that the guide wire was not subintimal and there were no observed dissection flaps present. After the third treatment pass on low speed with the oad, the crown of the oad caught a dissection flap, and the oad made a high-pitched noise. The oad was turned off and removed from the patient, and wire access was lost. When the device was removed, tissue was observed on the crown of the oad. The lesion was re-crossed, and the procedure was completed, and the type a dissection was treated with balloon angioplasty. Imaging after treatment confirmed there was a good result. The patient was okay following the procedure.
 
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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 55112
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
saint paul MN 55112
Manufacturer Contact
sarah hicks
1225 old highway 8 nw
saint paul, MN 55112
MDR Report Key9362830
MDR Text Key167787045
Report Number3004742232-2019-00306
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 11/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDBP-125MICRO145
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 Received11/18/2019
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: 11/22/2019 Patient Sequence Number: 1
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