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

Model Number DBEC-125

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Great Vessel Perforation (2152); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

This event was reported by the physician during a presentation during which csi employees were present.In good faith, please note that the individuals responsible for regulatory reporting were not notified of this event, resulting in submission of this report outside of the 30 day due date.Additional information regarding the patient demographics, device information and event details were requested, but were not available from the physician.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 reported oad could not be reviewed, as the lot number was not provided.If the lot number is provided, a dhr review will be performed.Suggested clinical code: slow/no flow.Csi id: (b)(4).

Event Description

Orbital atherectomy (oa) was selected for a heavily calcified and tortuous lesion located between stents in the right coronary artery.The diamondback coronary orbital atherectomy device (oad) was operated between the stents and imaging revealed a vessel perforation had occurred with no reflow.The patient experienced chest pain and became hypotensive.A balloon was used to tamponade the perforation and chest compressions were performed.Epinephrine was administered to restore distal flow and stent placements were performed along the left main.Flow was re-established, and the patient recovered.

• 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: 11828570
• MDR Text Key: 262654921
• Report Number: 3004742232-2021-00176
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2021

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: 09/17/2020
• Initial Date FDA Received: 05/14/2021
• 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): Required Intervention