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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 Entrapment of Device (1212); Unintended System Motion (1430)
Patient Problem Vascular Dissection (3160)
Event Date 03/09/2020
Event Type  Injury  
Manufacturer Narrative
The reported oad was received for analysis. Adhered biological material was observed on the crown, and embedded material was located in the driveshaft filars near the crown. Examination of the area did not reveal any damage that would have contributed to the accumulation. The morphology and exact root cause of the accumulating material was unknown. A guide wire was unable to pass through the area of embedded material. The guide wire was able to pass through the rest of the driveshaft and handle assembly with no resistance. The oad was tested, spun at all speeds, and functioned as intended with no issues observed. At the conclusion of the device analysis, the reported event was unable to be conclusively confirmed. The adhered material may have contributed to the reported event, however, this was unable to be confirmed. 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).
 
Event Description
During a procedure, the diamondback peripheral orbital atherectomy device (oad) was used to treat a 95% stenosed lesion in the proximal anterior tibial artery via posterior tibial access. The lesion was moderately to heavily calcified, and the vessel was 3. 5mm in diameter. The oad was used on low speed in a proximal to distal direction, and when medium speed was selected, the oad crown jumped. The oad was stuck on the wire, and low speed was selected to loosen it from the wire. The oad was then removed from the patient with a lot of resistance. A small, type a dissection was observed at the bend in the anterior tibial artery, and balloon angioplasty was used to resolve the dissection. The physician was concerned the oad may have fractured, and a second oad was used to continue the procedure in the posterior tibial artery. No physical damage was observed on the driveshaft or guide wire. The result of the procedure was good, and no additional patient complications were 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
saint paul, mn
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
saint paul, mn
Manufacturer Contact
sarah hicks
1225 old highway 8 nw
saint paul, mn 
MDR Report Key9917936
MDR Text Key192394934
Report Number3004742232-2020-00105
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 04/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Model NumberDBP-125MICRO145
Device Catalogue NumberDBP-125MICRO145
Device Lot Number239043
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/29/2018
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: 04/02/2020 Patient Sequence Number: 1
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