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

Model Number PRD-SC30-200

Device Problems Loss of Power (1475); Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 05/01/2015

Event Type  Injury  

Event Description

It was reported that during a peripheral orbital atherectomy procedure, the patient experienced an abrupt closure of the profunda artery after treatment with a csi orbital atherectomy device (oad).Additionally, the device got stuck on the guidewire and turned off during the procedure.The target lesion consisted of soft plaque and was located in the superficial femoral artery (sfa).The physician performed several runs at low, medium and at high speed using the oad, but during the final run, the device got stuck on the guidewire and turned off.After multiple removal attempts, the device was successfully removed off the wire.Post-atherectomy angiography revealed that the profunda artery had shut down.The physician resolved the vessel shut down by placing a stent.The patient status remained stable throughout the procedure.Requests for additional information have been made, but none has yet been received.

Manufacturer Narrative

Device analysis.The oad was returned without the original guidewire.The initial visual and tactile examination of the handle assembly, saline sheath and driveshaft revealed a bend in the driveshaft.Additionally, the strain relief was dislodged from the nosecone assembly.Further examination of the handle assembly revealed that the nosecone securing clips were damaged and fractured as a result of impact damage.The saline sheath was also damaged in this area.A kink in the driveshaft was observed 14.3cm distal to the adaptor hypotube lap weld.The exact cause of the damage could not be determined.Further examination revealed that the crown and distal tip bushing remained intact and undamaged.No biological material was observed on the driveshaft or crown.The outside diameter (od) of the crown and crown location on the driveshaft were measured and met the drawing specifications.The driveshaft was cut just proximal to the damage to allow further testing.An in-house 0.014" test wire was loaded through the device without issue.When tested, the device spun at low, medium 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 root cause of the vessel shut down could not be determined.The root cause of the device becoming stuck on the guidewire also could not be determined.It could not be determined whether or not the damage was a result of device manipulation during removal or a result of shipping and handling during return to csi.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: 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: 4801195
• MDR Text Key: 5931009
• Report Number: 3004742232-2015-00038
• Device Sequence Number: 1
• Product Code: MCW
• 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
• Report Date: 05/26/2015

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: PRD-SC30-200
• Device Lot Number: 123906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2015
• Initial Date FDA Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2015
• 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