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

Model Number EX-150SOL145

Device Problem Off-Label Use (1494)

Patient Problem Vascular Dissection (3160)

Event Date 06/04/2021

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the reported device was not returned for analysis.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.Based on the information received, the cause of the reported event could not be conclusively determined.However, the cause was traced to user error and intentional off-label use of the device since the operator did not follow guidance outlined in the diamondback 360® peripheral orbital atherectomy system exchangeable series instructions for use manual, which states, ".Maintain a travel rate between 1 mm per second and 10 mm per second." csi id: (b)(4).

Event Description

Despite guidance from csi field staff, the user of the diamondback exchangeable series orbital atherectomy device (oad) performed treatment at approximately 15cm per second in the superficial femoral artery.A 100cm spiral dissection occurred as a result of the failure to follow the instructions for use, which were repeatedly verbally provided to the user by field staff.A covered stent was placed to treat the dissection, and the patient was stable.

• Brand Name: DIAMONDBACK EXCHANGEABLE SERIES PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL 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: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 12075567
• MDR Text Key: 258641625
• Report Number: 3004742232-2021-00238
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2021

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: EX-150SOL145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2021
• Initial Date FDA Received: 06/28/2021
• 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
• Patient Age: 70 YR
• Patient Weight: 91