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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-EL14
Device Problems Entrapment of Device (1212); Material Deformation (2976)
Patient Problems Vascular Dissection (3160); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/27/2021
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
Orbital atherectomy treatment was successfully performed via left radial access to the left popliteal (pa) and common femoral arteries without issue, and the orbital atherectomy device was removed from the patient's body. A balloon was inserted over the viperwire guide wire to treat the pa and balloon angioplasty was successfully performed. During the removal process the balloon became stuck, and the guide wire was pulled, however a kink was observed in the guide wire which prevented the balloon from being removed. The sheath, balloon and wire were pulled back into the mid aorta and access to the right groin was obtained in order to snare the wire from below, however this attempt was unsuccessful. The balloon, wire and sheath were then removed from the radial access site. Imaging was performed and confirmed a type f dissection in the axillary artery and a vessel spasm in the radial artery. Vascular surgery was consulted, and it was determined that no further treatment was required and the patient would be monitored, however the following day a coronary bypass surgery was performed. The patient was discharged in stable condition.
 
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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 Key11890521
MDR Text Key262657517
Report Number3004742232-2021-00189
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,Followup
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVPR-GW-EL14
Device Catalogue Number7-10035-01
Device Lot Number362913-1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/16/2021
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: 05/26/2021 Patient Sequence Number: 1
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