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

Model Number DBEC-125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 06/27/2017

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 device history record for the oads were unable to be reviewed, as the lot numbers were not provided.Csi reached out to the director of intravascular imaging at the mount sinai medical center and requested additional information, but the director stated there was no additional information available for these events.The diamondback 360® coronary orbital atherectomy system instructions for use manual states slow flow or no reflow phenomenon are potential adverse events that may occur and/or require intervention during use of the system.(b)(4).Sareen, n., baber, u., aquino, m., sayseng, s., sayseng, s., sweeny, j.,.Sharma, s.(2017, june 27).Mid-term outcomes of consecutive 998 cases of coronary atherectomy in contemporary clinical practice.Journal of interventional cardiology.Doi:10.1111/joic.12398.[(b)(4)].

Event Description

A literature article was published on 27 june 2017 which indicated that four slow/no flow events occurred during procedures in which a diamondback coronary orbital atherectomy device was used.

• Brand Name: DIAMONDBACK CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul, mn
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul, mn
• Manufacturer Contact: morgan hill ; 1225 old hwy 8 nw; st. paul, mn
• MDR Report Key: 10086597
• MDR Text Key: 191976021
• Report Number: 3004742232-2020-00144
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/26/2020

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: 04/29/2020
• Initial Date FDA Received: 05/26/2020
• 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): Life Threatening
• Patient Age: 71 YR