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

Model Number PRD-SC30-200

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem Vascular Dissection (3160)

Event Date 08/12/2015

Event Type  Injury  

Manufacturer Narrative

The oad was received with the original guidewire engaged in the device.The initial visual examination of the handle assembly, driveshaft, and saline sheath did not reveal any damage.Further examination revealed accumulated biological material on the distal and proximal edges of the crown.The crown and distal tip bushing remained intact and undamaged.Examination of the filars surrounding the biological material accumulation did not reveal any damage or abnormalities that would have contributed to the 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 guidewire revealed accumulated biological material on the proximal spring tip solder bond area and on the shaft 18.2cm from the distal end of the spring tip.The guidewire was removed from the oad with no resistance.Examination in the areas of the adhered tissue did not reveal any damage that would have contributed to the biological material accumulation.The proximal spring tip solder bond area was observed to be damaged.The spring tip section was sent for scanning electron microscope (sem) analysis.Sem analysis identified possible degradation of the proximal solder bond.It could not be determined whether or not this was a result of the disinfection solution used during failure analysis or interaction with bodily fluid during the procedure.The exact cause of the condition of the solder could not be determined.Sem analysis did not identify any clear evidence of rotational damage on the guidewire spring tip.An in-house 0.014" test wire was loaded through the device with slight resistance met in the area of the adhered material.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.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 also could not be determined.The root cause of the device bogging down and locking on the guidewire could not be determined.Analysis identified adhered biological material on the driveshaft 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.Csi id (b)(4).

Event Description

It was reported that during a peripheral orbital atherectomy procedure, a csi orbital atherectomy device (oad) bogged down while spinning.Additionally, an arterial dissection occurred while using the oad.The target lesion was located in the superficial femoral artery (sfa).The oad was loaded onto the guidewire and advanced to the site of the lesion.During the second run with the oad, it bogged down and stopped spinning.The device and guidewire were removed as a unit and angiography revealed a dissection in the sfa.The patient status remained stable throughout the procedure.Additional information has been requested, but has not yet been received.The facility is clearing the release of information through their risk management department.

• 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: 5066600
• MDR Text Key: 25331775
• Report Number: 3004742232-2015-00058
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005053
• UDI-Public: (01)10852528005053(17)180331(10)122467
• 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
• Report Date: 09/01/2015

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: 03/31/2018
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: PRD-SC30-200
• Device Lot Number: 122467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2015
• 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