MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED STEALTH 360 ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number PRD-SC30-200

Device Problems Retraction Problem (1536); Device Operates Differently Than Expected (2913); Difficult to Advance (2920)

Patient Problem Vascular Dissection (3160)

Event Date 11/06/2015

Event Type  Injury  

Manufacturer Narrative

The oad was received with the original guide wire engaged in the device.The initial visual and tactile examination revealed damage to the driveshaft at the nose cone assembly.The driveshaft and engaged guide wire were kinked at this location.The crown and distal tip bushing remained intact and undamaged.Biological material was observed on the driveshaft and crown.Examination of the driveshaft and crown did not reveal any damage that would have contributed to the tissue accumulation.The outside diameter (od) of the driveshaft and crown location on the driveshaft were measured and met the drawing specifications.Examination of the exposed sections of the guide wire revealed accumulated biological material on the guide wire proximal spring tip solder bond area.The spring tip did not exhibit any visible damage that would have contributed to the tissue accumulation.The guide wire was removed distally from the driveshaft with significant resistance.Examination of the remaining section of the guide wire revealed a kink that coincided with the driveshaft kink.An attempt was made to load an in-house.014" test wire through the driveshaft and handle assembly, but met resistance at the location of the driveshaft damage.The driveshaft was destructively cut proximal to the damaged filars and the 0.014" test wire was then reloaded into the device without any resistance.The oad was tested using an in-house saline pump and spun at low, medium, and at high speeds with no abnormalities observed.The control knob was visually examined and no damage was 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.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.The material inspection report for the viperwire was not reviewed as the lot number is unknown.At the conclusion of the failure analysis investigation, the root cause of the dissection could not be determined.The root cause of the device bogging down and locking on the guide wire could not be determined.Analysis identified adhered biological material on the driveshaft, crown, and guidewire; however, the device did not exhibit any damage that would have led to the difficulties experienced during the procedure or the noted biological material accumulation.(b)(4).

Event Description

It was reported that during a peripheral orbital atherectomy procedure, a dissection occurred while using a csi orbital atherectomy device (oad).The target lesion was located in the superficial femoral artery (sfa), 25cm in length and 90% calcified.The physician used a.014 command guide wire and cxi.018 crossing catheter to access the lesion and then exchanged the guide wire for a csi peripheral viperwire guide wire.The physician then removed the cxi catheter and loaded a csi oad onto the guide wire.The physician completed runs at low and high speeds.The physician then advanced the crown distally and met some resistance, but after a few seconds was able to successfully advance and continue treatment.Two runs at low speed and one run at medium speed were then performed.During the final run, the physician noted an unusual sound.An attempt was made to remove the oad, but the device was stuck on the guide wire.The device and guide wire were removed as a unit and angiography revealed a dissection in the distal common femoral artery (cfa) and proximal sfa.The patient was then taken to the or for surgical intervention, but remained in stable condition.Additional information has been requested, but has not yet been received.

Event Description

Additionally, it was identified that, after removal of the oad, the angiography revealed an obstructing thrombus or endarterectomy segment in the cfa with embolization to the profunda and the sfa was occluded.The patient was then taken to the or for thromboendarterectomy and femoral popliteal bypass.

• Brand Name: STEALTH 360 ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL 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: 5266989
• MDR Text Key: 32672884
• Report Number: 3004742232-2015-00083
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005053
• UDI-Public: (01)10852528005053(17)180930(10)138905
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2018
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: PRD-SC30-200
• Device Lot Number: 138905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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