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

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)

Event Date 08/04/2023

Event Type  Injury  

Manufacturer Narrative

H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that vessel perforation is a potential adverse event that may occur and/or require intervention with use of the system.The device history record for the reported oad could not be reviewed as the lot number was not provided.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.Csi id: (b)(4).

Event Description

A diamondback 360 coronary orbital atherectomy device (oad) was used to treat tortuous 90% stenosed ostial left anterior descending (lad) artery, 90% stenosed mid lad, and moderate ostial left circumflex artery.During treatment, the oad caused a perforation.After treatment, the patient experienced abrupt hypotension.A stent was placed, balloon angioplasty was utilized, and pericardiocentesis was performed.The patient was hospitalized and in stable condition.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: aaron stevens ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 17691293
• MDR Text Key: 322744270
• Report Number: 3004742232-2023-00231
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/06/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 09/06/2023
• 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
• Patient Age: 80 YR
• Patient Sex: Female