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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE

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CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE Back to Search Results
Model Number DBP-125MICRO145
Device Problem Unintended System Motion (1430)
Patient Problems Perforation (2001); Vascular Dissection (3160); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/10/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Device analysis results: the oad was returned to csi for analysis with the guide wire not engaged in the device. Analysis revealed biological material embedded within the driveshaft filars near the crown; this prevented the guidewire from passing through during testing, which may confirm the report that the device became stuck on the guide wire. Examination did not reveal any damage that would have contributed to the accumulation. The morphology and exact root cause of the accumulation is unknown. The crown was measured and found to have met drawing specifications. When tested, the oad functioned as intended. The reports that the crown jumped, slow/no flow occurred, and dissection and perforation occurred were not confirmed. There was no damage or abnormalities observed with the driveshaft or handle that would have contributed these reported issues. The opinion of the physician was that the device contributed to the reported events, though the perforation occurred as a result of angioplasty used to address the reported dissection. Csi id: (b)(4).
 
Event Description
Treatment was performed via left femoral access with a diamondback peripheral orbital atherectomy device (oad) in the popliteal and proximal anterior tibial artery (at), each of which was 80% stenosed. The vessel diameter was 3mm, and the lesions were moderately calcified. The proximal at lesion was treated on low, medium, and high speed for 15 seconds each. During the final treatment, the user felt the device jump backwards, and the device became stuck on the guide wire. The use of glideassist did not resolve the issue. The oad and wire were removed from the patient, and the vessel was rewired. Angiography showed no flow in the vessel and a dissection in the proximal at. Angioplasty was performed. Thereafter, a perforation was observed. The balloon was reinserted and inflated for five minutes. The procedure was delayed by 30 minutes or more due to time taken to rewire the vessel. The patient was stable with no complaint of pain.
 
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Brand NameDIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Type of DevicePERIPHERAL ATHERECTOMY DEVICE
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old hwy 8 nw
st. paul MN 55112
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old hwy 8 nw
st. paul MN 55112
Manufacturer Contact
morgan hill
1225 old hwy 8 nw
st. paul, MN 55112
MDR Report Key11962244
MDR Text Key255082583
Report Number3004742232-2021-00208
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 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDBP-125MICRO145
Device Catalogue Number7-10057-01
Device Lot Number338154
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/29/2020
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: 06/08/2021 Patient Sequence Number: 1
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