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

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/27/2019

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: csi contacted the corresponding author of the article and requested model numbers and lot numbers, but neither were available.Csi also requested information regarding possible return of any of the devices, but information regarding availability of the devices was not available.If the devices do become available, they will be analyzed.The results of the investigation are inconclusive since the reported devices were not returned for analysis.Based on the information received, the cause of the reported events 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.Date of article is 10 june 2020; however, csi is aware that the events occurred on or before (b)(6) 2019.Known inherent risk of device: the diamondback360® peripheral orbital atherectomy system instructions for use manual states that thrombus is a potential adverse event that may occur with use of the system.Date received by manufacturer - due to an inadvertent delay in notification of the events within the article to postmarket surveillance, the mdr was not sent within 30 days of a csi employee becoming aware.Additional training was provided regarding csi's procedures for reporting complaints to postmarket surveillance.E.Ivan, b.Martinsen, z.Igyarto, et al., peripheral artery disease in vulnerable patient populations: outcomes of orbital atherectomy in native americans compared to non-native americans.A single center experience in rural oklahoma, cardiovascular revascularization medicine (2020), https://doi.Org/10.1016/j.Carrev.2020.06.008.Csi id: (b)(4).

Event Description

Ivan et al., 2020 - a literature article was published in june 2020 which indicated the following: during procedures in which csi peripheral orbital atherectomy devices (oads) were used, one instance of thrombus occurred.

• Brand Name: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY SYSTEM
• 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: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 11096588
• MDR Text Key: 224858511
• Report Number: 3004742232-2020-00428
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• 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: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• 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
• Date Manufacturer Received: 03/27/2019
• 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): Other