MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY DEVICE

Model Number DBEC-125

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

Patient Problems Death (1802); Loss of consciousness (2418); Cardiac Perforation (2513)

Event Date 03/22/2018

Event Type  Death  

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.(b)(4).

Event Description

During a coronary atherectomy procedure using a csi orbital atherectomy device (oad), a perforation occurred and the patient expired.The target lesion was located in the right coronary artery (rca) and was treated using one pass with the oad on low speed.When the device was retracted, a perforation was noted.The oad was removed and two stents were deployed across the perforation.The patient became unstable and lost consciousness, and cardiopulmonary resuscitation was performed.The patient was intubated and insertion of a ventricular assist device was attempted, however severe stenosis prevented insertion.Balloon angioplasty was performed inside the stent and an additional stent was placed in the proximal rca.Although the patient was in stable condition at the end of the procedure, it was reported that the patient expired following the procedure.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 7430473
• MDR Text Key: 105454521
• Report Number: 3004742232-2018-00104
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005169
• UDI-Public: (01)10852528005169(17)200131(10)213632
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2018

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 Expiration Date: 01/31/2020
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-02
• Device Lot Number: 213632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2018
• 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
• Patient Age: 62 YR
• Patient Weight: 52