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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY DEVICE

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CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY DEVICE Back to Search Results
Model Number DBEC-125
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Type  Death  
Manufacturer Narrative
Csi contacted (b)(4) (distributor) in the geography where these events occurred in order to attempt to obtain the complaint devices and event informaton, and additional information has not yet been received.If additional information is received, a supplemental report will be submitted.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.Yutaka tanaka, shohei yokota, takahiro hayashi, hirokazu miyashita, hiroaki yokoyama, kazuki tobita, koki shishido, shingo mizuno, futoshi yamanaka, saeko takahashi, and shigeru saito.Procedural and clinical outcomes with the diamondback 360 orbital atherectomy system: a classic crown with glideassist and viperwire advance flextip j am coll cardiol.2020 mar, 75 (11_supplement_1) 1237.Serious injury information received in this literature article is reported in mdr 3004742232-2021-00130.Csi id: (b)(4).
 
Event Description
Tanaka et al.2020 - a literature article was published 24 march 2020 and indicated that cardiac deaths was 2.1%.Per the physician, the csi devices and wires did not cause the myocardial infarction, target vessel revascularization or cardiac deaths but may have contributed.
 
Manufacturer Narrative
Corrected field: b4.The initial mdr was submitted with an incorrect date of report, the date of report for the initial report should have been 14-apr-2020.Csi id: (b)(4).
 
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Brand Name
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
Type of Device
CORONARY ATHERECTOMY DEVICE
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
saint paul MN 55112
MDR Report Key11661062
MDR Text Key245303568
Report Number3004742232-2021-00129
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
PMA/PMN Number
P130005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,litera
Type of Report Initial,Followup
Report Date 04/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberDBEC-125
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/15/2021
Initial Date FDA Received04/13/2021
Supplement Dates Manufacturer Received04/20/2021
Supplement Dates FDA Received04/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
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