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

Model Number DBEC-125

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Occlusion (1984); Ventricular Fibrillation (2130); Vascular System (Circulation), Impaired (2572)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

The device was discarded by the facility; therefore, an analysis of the actual complaint device is not possible.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.(b)(4).

Event Description

It was reported that during a coronary orbital atherectomy procedure, the patient went into ventricular fibrillation (vf), which required additional intervention.There were two target lesions in the mid and distal right coronary artery (rca) located at the bifurcation of the posterior descending artery (pda) and posterolateral artery (pla).The physician introduced the guide catheter into the patient and advanced the csi viperwire guide wire across the lesion.The csi oad was then loaded onto the guide wire and advanced to the distal lesion.The physician performed a pre-atherectomy angiography to verify that the oad crown was close to the distal lesion.Angiography revealed that the csi oad had occluded the vessel in the mid-rca lesion, stopping the flow of blood to the distal region of the vessel.The physician then pulled the oad proximally, which returned low pressure blood flow to the vessel.As the guide catheter was being retracted proximally, the patient went into vf which triggered a shock by his internal defibrillator.The patient was administered dopamine and blood pressure returned to baseline level after a few minutes.The atherectomy procedure was aborted due to this event and the physician completed the intervention via balloon angioplasty and stent placement.The patient was discharged in stable condition.

• 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: 5187843
• MDR Text Key: 29838692
• Report Number: 3004742232-2015-00073
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005169
• UDI-Public: (01)10852528005169(17)170630(10)130284
• 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: 10/28/2015

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 Expiration Date: 06/30/2017
• Device Model Number: DBEC-125
• Device Catalogue Number: DBEC-125
• Device Lot Number: 130284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2015
• Initial Date FDA Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: No
• 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