MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY DEVICE

Model Number DBEC-125

Device Problem Entrapment of Device (1212)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Death (1802); Vascular Dissection (3160)

Event Date 12/08/2016

Event Type  Death  

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).

Event Description

It was reported that during a coronary orbital atherectomy procedure, a csi orbital atherectomy device (oad) got stuck in the patient and required surgical intervention.The entire right coronary artery (rca) was diffusely diseased and had been previously treated with multiple stents.A jr4 and a csi viperwire guide wire were used to access the lesion.The physician loaded the oad onto the guide wire and advanced it just proximal to the lesion.The physician performed two runs at low speed with no issue.During the next run at high speed, a pitch change was heard in the oad and the crown appeared to jump distally.No angiographic complications were observed, but the oad was stuck and could not be pulled back.Multiple different attempts to remove the device were made, but were unsuccessful.At this point, the patient's vitals were stable, but the patient started to complain of arm pain.The patient was taken to surgery for removal of the oad.During surgery, the oad was successfully removed, but an aortic dissection led to the patients status declining and the patient expired.Additional information has been requested, but none has yet been received.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• 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 hwy 8 nw; saint paul, MN 55112 ; 6512592819
• MDR Report Key: 6198021
• MDR Text Key: 63073577
• Report Number: 3004742232-2016-00149
• Device Sequence Number: 1
• Product Code: MCX
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2016

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: DBEC-125
• Device Catalogue Number: DBEC-125
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/22/2016
• 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): Death