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

Model Number DBEC-125

Device Problem Insufficient Information (3190)

Patient Problem Myocardial Infarction (1969)

Event Type  Injury  

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 information, 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.The patient death information received in this literature article is reported in mdr 3004742232-2021-00129.Csi id: (b)(4).

Event Description

Tanaka et al.2020 - a literature article was published 24 march 2020 and indicated that myocardial infarction, target vessel revascularization and 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.

• 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
• 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 Key: 11663602
• MDR Text Key: 261738049
• Report Number: 3004742232-2021-00130
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2021

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 Number: DBEC-125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other