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

Model Number DBEC-125

Device Problem Difficult to Advance (2920)

Patient Problem Occlusion (1984)

Event Date 01/23/2014

Event Type  Injury  

Event Description

It was reported that during a coronary orbital atherectomy procedure, an abrupt closure of the ramus intermedius artery occurred.The target lesion was 99% stenotic, 8.0mm in length and was located in the ramus intermedius artery.The physician used a 7fr introducer sheath and a 7fr guide catheter to access the lesion.He advanced a csi coronary viperwire to the site of treatment and loaded a csi orbital atherectomy device (oad) onto the viperwire.He performed two runs at low speed (60 seconds total) and one run at high speed (15 seconds total) in attempt to cross the lesion, but was unsuccessful.He then attempted to cross the lesion using a cutting balloon, but again was unsuccessful.Approximately 20 minutes post cutting balloon attempt, the ramus intermedius artery abruptly closed.He re-wired the vessel and completed the case via rotational atherectomy.He was then able to complete the intervention using balloon angioplasty followed-up with stent placement.Arterial blood flow was restored to the vessel and the patient status remained stable.Additional information has been requested from the facility, but none has yet been received.

Manufacturer Narrative

Device analysis.The oad was returned with the original guide wire engaged in the device.The initial visual and tactile examination of the handle assembly, saline sheath and driveshaft revealed a kink in the driveshaft 6cm distal to the edge of the strain relief with the control knob in the full forward position.It should be noted that the kink is not considered a contributing factor to the difficulties experienced during the procedure.Further examination revealed that the crown and distal tip bushing remained intact and undamaged.Biological material was observed on the driveshaft and crown.Further examination of the driveshaft and crown did not reveal any damage that would have contributed to the biological material accumulation.Examination of the distal and proximal exposed sections of the guide wire did not reveal any damage that would have contributed to the noted event.Further examination of the guide wire revealed that the spring tip and proximal adhesive bond remained intact and undamaged.Biological material was also observed on the distal exposed guide wire shaft section at the driveshaft tip bushing.The guide wire was removed distally from the handle assembly with significant resistance.Examination of the guide wire revealed a kink in the shaft that coincided with the driveshaft kink.Once the guide wire was removed, the driveshaft kink was no longer present.An in-house coronary guide wire was loaded through the device without issue.When tested using an in-house saline pump the device spun during at low and high speed with no abnormalities observed.The device was turned on and off numerous times with no issues observed.While performing functional testing the power cord, brake and control knob were manually manipulated to determine if there were any functional concerns with the components that would have contributed to the reported event.The device and its components functioned as intended with no abnormalities observed.The outside diameter of the crown and crown location on the driveshaft were measured and met their drawing specifications.At the conclusion of the failure analysis investigation, the root cause of the reported event could not be determined.The device and its components were within specification, performed as intended and no defects were found.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.Csi id# 01163.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 651 campus drive; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED; 651 campus drive; saint paul MN 55112
• Manufacturer Contact: megan brandt ; 651 campus drive; saint paul, MN 55112 ; 6512592805
• MDR Report Key: 3639564
• MDR Text Key: 17614113
• Report Number: 3004742232-2014-00011
• 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: 02/14/2014

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: 11/30/2015
• Device Model Number: DBEC-125
• Device Catalogue Number: DBEC-125
• Device Lot Number: 89954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2014
• Initial Date FDA Received: 02/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2013
• 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: 67 YR