MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (VIPERWIRE); PERIPHERAL ORBITAL ATHERECTOMY DEVICE (GUIDE WIRE)

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

Patient Problem Vascular Dissection (3160)

Event Date 09/22/2020

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 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.The diamondback 360® peripheral orbital atherectomy system potential adverse event that may occur and/or require intervention.(b)(4).

Event Description

The viperwire guide wire was advanced without observation on imaging.A dissection occurred.The dissection was resolved with angioplasty, and the procedure was completed successfully.

Manufacturer Narrative

Corrected data: h10.H6 conclusion code 22: known inherent risk of device - the diamondback 360® peripheral orbital atherectomy system instructions for use states that a dissection is a potential adverse event that may occur and/or require intervention.

• Brand Name: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (VIPERWIRE)
• Type of Device: PERIPHERAL ORBITAL ATHERECTOMY DEVICE (GUIDE WIRE)
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 10710091
• MDR Text Key: 212248622
• Report Number: 3004742232-2020-00326
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other