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

Model Number DBEC-125

Device Problem No Apparent Adverse Event (3189)

Patient Problems Low Blood Pressure/ Hypotension (1914); Left Ventricular Failure (1948)

Event Date 06/10/2020

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 this oad 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.The diamondback 360 coronary orbital atherectomy system instructions for use manual states that hypotension and heart dysfunciton are potential adverse events which can occur with use of the system.(b)(4).

Event Description

One low speed treatment was administered with the diamondback coronary orbital atherectomy device (oad) in the left anterior descending artery (lad) via femoral access.The patient became unstable.The oad was removed, and the patient was stabilized with medication and ventricular assist device support.The procedure was continued after the patient was stabilized.In the opinion of the physician, the patient may have become unstable due to higher than anticipated reliance on flow from the lad.

• 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: 10174174
• MDR Text Key: 195745895
• Report Number: 3004742232-2020-00169
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005787
• UDI-Public: (01)10852528005787(17)220131(10)305899
• 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: 06/19/2020

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 Expiration Date: 01/31/2022
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-13
• Device Lot Number: 305899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2020
• 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