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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-125MICRO60
Device Problem Noise, Audible (3273)
Patient Problems Bruise/Contusion (1754); Vascular Dissection (3160)
Event Date 02/22/2019
Event Type  Injury  
Manufacturer Narrative
The reported oad was received for analysis. An initial visual examination of the handle assembly, saline sheath and driveshaft did not reveal any damage. The crown and distal tip bushing were intact and undamaged. Adhered biological material was observed on the driveshaft and crown. Examination of the area of adhered biological material did not reveal any damage which would have contributed to the accumulation. The morphology and root cause of the biological material is unknown, and it could not be determined if it was related to the reported dissection. A guide wire was inserted and passed through the oad with no resistance. The device was tested on all three speeds and was found to function as intended with no anomalies or unusual noises noted. At the conclusion of the device analysis investigation, the reports of dissection and an unusual noise were unable to be confirmed through analysis. The device history record for this oad lot number has been reviewed. No issues or discrepancies were noted during this review that would have contributed to the reported event. The device met material, assembly, and quality control requirements prior to distribution. Csi id: (b)(4).
 
Event Description
During a peripheral atherectomy procedure using a csi diamondback orbital atherectomy device (oad), a dissection occurred. During atherectomy treatment, the device made an unusual noise. Following removal of the oad, a dissection was noted in the area of the sheath. A balloon was inflated at the site of the dissection for three minutes to resolve it and the patient was in stable condition. Per the physician, the cause of the dissection was unknown. The patient presented with bruising the day following the procedure. No additional patient complications have been reported.
 
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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
st. paul MN 55112
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
st. paul MN 55112
Manufacturer Contact
laramie otto
1225 old highway 8 nw
st. paul, MN 55112
6512691600
MDR Report Key8475233
MDR Text Key140676361
Report Number3004742232-2019-00093
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133399
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 04/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Model NumberDBP-125MICRO60
Device Catalogue NumberDBP-125MICRO60
Device Lot Number216293
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2018
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: 04/02/2019 Patient Sequence Number: 1
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