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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 VPR-GW-FLEX14
Device Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/05/2020
Event Type  Injury  
Manufacturer Narrative
The results of the investigation are inconclusive since the reported device was not returned for analysis. Based on the information received, the cause of the reported event could not be conclusively determined. The material inspection report for this guide wire 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
Orbital atherectomy (oa) treatment was successfully performed in the peroneal artery via antegrade approach. The peripheral orbital atherectomy device (oad) and viperwire guide wire were removed from the patient's body, and the guide wire was reinserted into the sheath. A balloon was inserted over the viperwire guide wire to continue treatment, however the guide wire fractured. The fracture occurred due to the 45 degree bend in the 6 french sheath located near the proximal common femoral artery, which was due to the tortuosity of the superficial and common femoral arteries. A balloon was inserted into the sheath to trap the wire, and the wire was removed from the patient's body. Treatment to the peroneal artery was completed, and the procedure continued with oa treatment in the posterior tibial artery. There were was no patient harm. Per the physician, both the kink in the sheath and utilizing the viperwire guide wire as the primary wire caused the fracture event. Treatment with the oad likely exhibited stress on the guide wire at the kinked area, but there was no issue specifically with the guide wire or oad.
 
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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 Key11055014
MDR Text Key223135019
Report Number3004742232-2020-00419
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 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Model NumberVPR-GW-FLEX14
Device Catalogue Number7-10041-03
Device Lot Number246260
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/29/2018
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: 12/22/2020 Patient Sequence Number: 1
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