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

Model Number DBEC-125

Device Problems Difficult to Advance (2920); No Flow (2991)

Patient Problem No Information (3190)

Event Date 05/19/2015

Event Type  Injury  

Event Description

It was reported that during a coronary orbital atherectomy procedure, a no flow event occurred after using a csi coronary orbital atherectomy device (oad).The target lesion was located in the mid-to-distal right coronary artery (rca).It should be noted that a stent had previously been placed in the proximal rca.The physician used a 6fr finecross guide catheter to access the lesion.The physician successfully passed the finecross through the stent, but it seemed to be getting caught up in the stent location.A csi coronary viperwire guidewire was advanced across the lesion and the oad was loaded onto it.When advancing the oad to the site of the lesion, the device was unable to cross the area of the previously placed stent.The physician removed the oad and pre-dilated the area with a balloon, and was then able to pass the oad through the stent.The physician performed three runs at low speed using the oad.Post-atherectomy angiography revealed no flow in the distal rca.The viperwire was then exchanged for a new guidewire and the physician performed balloon angioplasty in an attempt to resolve the no flow event.With little improvement to the flow, the physician then placed a stent, but slow flow remained.The physician then administered additional adenosine and verapamil, but slow flow remained.The patient status remained stable throughout the procedure and left in stable condition.The physician discharged the patient with instructions to take plavix, and plans to re-intervene at a later date.

Manufacturer Narrative

The device is being retained and 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).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY DIAMONDBACK ORBITAL 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: 4824134
• MDR Text Key: 5913581
• Report Number: 3004742232-2015-00039
• 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: 06/03/2015

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: 04/30/2017
• Device Model Number: DBEC-125
• Device Catalogue Number: DBEC-125
• Device Lot Number: 125386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2015
• Initial Date FDA Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2015
• 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