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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 Problem Entrapment of Device (1212)
Patient Problems Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Event Date 05/11/2021
Event Type  Injury  
Manufacturer Narrative
The reported oad was received at csi for analysis, engaged on the guide wire. Visual examination revealed adhered biological material on the proximal and distal edge of the driveshaft crown. A guide wire was inserted into the oad and met some resistance at the area of adhered material, and was able to pass through the remaining driveshaft without issue. When tested, the oad was powered on and off and spun on all speeds. Review of the device data log revealed numerous stall conditions. At the conclusion of the device analysis investigation, the reported dissection and stuck in vessel events could not be confirmed through analysis. The accumulated tissue may have contributed to the dissection and stuck in vessel events, however this could not be confirmed. There was no damage observed that would have contributed to the material accumulation and the root cause of the accumulated material was unknown. 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. Csi id: (b)(4).
 
Event Description
The diamondback coronary orbital atherectomy device (oad) was operated for several treatment passes in the posterior tibial (pt) artery, and during the removal process the oad could not be removed from the patient's body. Glideassist was activated, and the oad momentarily spun before it stopped spinning. Nitroglycerin was administered, however the oad remained stuck in the vessel. The oad and wire were removed and wire access was lost. A type f dissection was observed in the lateral plantar artery and balloon angioplasty was used to resolve the dissection.
 
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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
brittany leider
1225 old highway 8 nw
saint paul, MN 55112
6512591600
MDR Report Key11966755
MDR Text Key255353916
Report Number3004742232-2021-00207
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 06/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDBP-125MICRO145
Device Catalogue Number7-10057-01
Device Lot Number350406-1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/14/2021
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: 06/09/2021 Patient Sequence Number: 1
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