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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-150SOLID145
Device Problem Unexpected Shutdown (4019)
Patient Problem Vascular Dissection (3160)
Event Date 11/09/2018
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
During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), a dissection occurred. During treatment of a lesion in the superficial femoral artery (sfa), the device stopped spinning. Upon removal of the oad, imaging was performed and a type a dissection was noted. The guide wire was observed to be in a false lumen, and the location was corrected. Balloon angioplasty was performed and an unplanned stent was placed to resolve the dissection. The patient was in stable condition following the procedure.
 
Manufacturer Narrative
The reported oad was received for analysis. Adhered biological material was observed on the driveshaft filars and crown. The material did not prevent a guide wire from passing through the device, and examination of the areas of adhered tissue did not reveal any damage which may have contributed to the accumulation. When tested, the device functioned as intended with no anomalies observed. It is possible that the device became wrapped in biological material which led to a stall condition, however this could not be conclusively 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. (b)(4).
 
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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
MDR Report Key8125965
MDR Text Key129089626
Report Number3004742232-2018-00361
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
PMA/PMN Number
K133399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2019
Device Model NumberDBP-150SOLID145
Device Catalogue NumberDBP-150SOLID145
Device Lot Number201099
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/03/2018 Patient Sequence Number: 1
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