MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED UNKNOWN

Model Number UNKNOWN

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Tissue Damage (2104)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

The device was discarded by the facility; therefore, an analysis of the actual complaint device is not possible.The lot number was not recorded and could not be obtained.(b)(4).Unknown device disposition.

Event Description

It was reported that during a peripheral orbital atherectomy procedure, a device issue occurred that damaged an artery in a patient's leg.This led to further complications, but the exact complications are unknown.This event was reported to csi by a physician during an internal meeting.It should be noted that the date of event is an approximation and it not exactly known.Additional information is being requested regarding this event.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: jacob mellem ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 6542756
• MDR Text Key: 74356354
• Report Number: 3004742232-2017-00047
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2017

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: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 05/03/2017
• 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