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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-14
Device Problems Unintended System Motion (1430); Material Separation (1562)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/18/2018
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 prior to distribution. (b)(4).
 
Event Description
During a peripheral atherectomy procedure using a csi diamondback orbital atherectomy device (oad), the tip of the viperwire guide wire became detached and remained in the patient. The target lesion was 95% stenosed and located in the anterior tibial artery. When the viperwire was advanced to lesion, the physician was advised to advance the wire further and declined to do so. The lesion was treated with three passes with the oad. The device was advanced and additional passes were performed. During a pass on high speed, the oad crown was noted to jump forward and the wire became detached. The oad and viperwire were withdrawn and a non-csi guide wire was inserted. The wire fragment was secured to the vessel wall with a stent. The patient was discharged in stable condition following the procedure.
 
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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
laramie otto
1225 old highway 8 nw
saint paul, MN 55112
6512591600
MDR Report Key8246297
MDR Text Key133045486
Report Number3004742232-2019-00026
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151260
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 01/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Model NumberVPR-GW-14
Device Catalogue Number72023-01
Device Lot Number244119
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 Received12/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/17/2018
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: 01/14/2019 Patient Sequence Number: 1
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