MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED 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 Bradycardia (1751); Ventricular Tachycardia (2132)

Event Date 10/21/2015

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.(b)(4).Discarded by facility.

Event Description

It was reported that during a coronary orbital atherectomy procedure, the patient became bradycardic and went into ventricular tachycardia.The target lesion was located in the right coronary artery (rca).The physician used a 5fr introducer sheath and placed a temporary pacemaker on the venous side of the patients heart.A 6fr introducer sheath, (b)(4) guide wire and choice pt wire were used to access the lesion.The physician exchanged the choice pt wire for a csi viperwire guide wire and advanced it across the lesion.A csi coronary orbital atherectomy device (oad) was loaded onto the guide wire and advanced to the site of the lesion.One run was performed at low speed, but did not cross the lesion.A second and third run were performed at low speed, but again did not cross the lesion.At this point, the patient's blood pressure had dropped, but heart rate remained steady with no use of the pacemaker.A fourth run was performed, with the same result as the first three runs.During the fifth run at low speed, the patient started complaining of chest pain and became restless on the table.Angiography revealed that the vessel remained open, but aortic pressure was dampened as the guide catheter had kicked back into the aorta.The device was removed from the patient and an attempt to treat with a 1.25 sprinter balloon was made.As the wire was advanced, the guide catheter again kicked out.Angiography now revealed that the rca had shut down and the patient became ectopic and bradycardic.After two minutes of trying to re-wire the vessel, the patient went into ventricular tachycardia and became unresponsive.The patient was defibrillated five times and rhythm was returned.Again the vessel was re-wired and a 1.2x10mm balloon was passed across the lesion.Multiple inflations were performed, but follow-up angiography revealed perfusion and a few dissections.The patient was taken to surgery for a repeat cabg procedure.

• 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: megan brandt ; 1225 old hwy 8 nw; saint paul, MN 55112 ; 6512592805
• MDR Report Key: 5228050
• MDR Text Key: 31318467
• Report Number: 3004742232-2015-00078
• 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: 11/12/2015

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: 10/21/2015
• Initial Date FDA Received: 11/16/2015
• 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: 63 YR