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

Model Number DBEC-125

Device Problems Kinked (1339); Split (2537); Device Operates Differently Than Expected (2913)

Patient Problem Cardiac Arrest (1762)

Event Date 10/20/2014

Event Type  Injury  

Event Description

It was reported that during a coronary orbital atherectomy procedure, a dissection occurred while using a csi orbital atherectomy device (oad).During removal from the package, a kink was observed on the oad driveshaft, but the physician decided to proceed with the procedure using that oad.While advancing the device to the site of treatment, the physician noted tracking difficulty.The physician attempted to spin through the lesion on low speed, but the device jumped forward.The first oad was removed and a second oad was used to complete atherectomy.Post-atherectomy, a dissection was noted under angiography.Additionally during the procedure, the patient coded, but was able to be revived.Three requests for additional information has been made, but none has yet been received.

Manufacturer Narrative

Device analysis: the oad was received without the original guidewire or saline line.The initial visual examination of the handle assembly, saline sheath and driveshaft revealed a kink in the saline sheath 44cm distal to the nose cone assembly.Further examination revealed that the crown and distal tip bushing remained intact and undamaged.Biological material was observed on the driveshaft and crown.Examination in the area of the tissue did not reveal any damage that would have contributed to the tissue accumulation.The saline sheath was removed from the handle assembly and visual examination of the driveshaft revealed a kink in the shaft 49.6cm distal to the lap weld.The kink in the driveshaft coinicided with the location of the saline sheath kink.The crown dimensions and location on the driveshaft were measured using a calibrated dial caliper and met the drawing specifications.The driveshaft and saline sheaths were measured and found to meet their respective drawing specifications.An in-house 0.014" test wire was loaded through the device and resistance met in the location of the kink.When tested, the device spun at low and at 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 components functioned as intended with no abnormalities observed.At the conclusion of the failure analysis investigation, the driveshaft kink was confirmed; however, the etiology of the event could not be determined.The root cause of the dissection could not be determined.The device was within specification and performed as intended during functional testing.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; 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: 4262706
• MDR Text Key: 5032136
• Report Number: 3004742232-2014-00056
• 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: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2016
• Device Model Number: DBEC-125
• Device Catalogue Number: DBEC-125
• Device Lot Number: 111762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2014
• 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