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 Bradycardia (1751); Chest Pain (1776); Perforation of Vessels (2135); Vascular Dissection (3160)

Event Date 12/14/2022

Event Type  Injury  

Event Description

An intravascular ultrasound (ivus) catheter was unable to be advanced in the proximal right coronary artery (rca).A non-csi balloon was used in the proximal lesion and at the ostium.Ivus still was unable to be advanced.A diamondback 360 coronary orbital atherectomy device (oad) was used to treat the 8-90% stenosed proximal and ostial rca.During the first treatment on low speed, the patient experienced bradycardia.A half dose of atropine was administered and patient stabilized.Three additional retrograde treatments were performed on low speed.The patient experienced chest pain.Imaging was performed and revealed a perforation.Balloon tamponade was attempted unsuccessfully.Two covered stents were placed in the proximal rca and ostial rca with restored flow.Pericardiocentesis was performed successfully.The drain was left in place.During this time, the patient's blood pressure began to drop.A neo-synephrine drip was administered which was converted to a levophed and dopamine drip.Final imaging confirmed the perforation was sealed with a dissection extending into the ascending aorta and into the right aortic cusp.The patient was intubated to assist with stabilizing.The patient was transferred to another facility for possible thoracic surgery.Follow up computed tomography scan revealed no aortic dissection present.The patient was stable and no further intervention was scheduled.

Manufacturer Narrative

The oad was returned to csi for analysis.Biological material was observed on the driveshaft located at the crown section.The morphology and exact root cause of the accumulated biological material is unknown.No damage was observed.When tested, the oad functioned as intended.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.Investigation conclusion code 22: the diamondback 360® peripheral orbital atherectomy system instructions for use manual states that vessel perforation and dissection are a potential adverse event that may occur and/or require intervention with use of the system.Csi id: (b)(4).

• 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: tonia moskalets ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 16162935
• MDR Text Key: 307468382
• Report Number: 3004742232-2023-00011
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)241031(10)455669-1
• 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: 01/13/2023

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
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-09
• Device Lot Number: 455669-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2022
• 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): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White