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

Model Number PRD-SC30-200

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Vascular Dissection (3160)

Event Date 03/11/2016

Event Type  Injury  

Manufacturer Narrative

The device is anticipated to be received at csi for analysis, but has not yet been returned.(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 90% stenotic and was located in the superficial femoral artery (sfa).The physician used a 7fr introducer sheath to access the lesion.A csi viperwire guide wire was advanced into the patient and the oad was loaded onto it.The physician performed three runs at low speed and one run at medium speed to treat the lesion.During the final run, the oad felt as if it were stuck on the guide wire.There was an audible pitch change on the oad and the physician noted that it was stuck.The oad and guide wire were removed as a unit and follow-up angiography revealed a dissection at the distal end of the lesion.The physician deployed a stent across the dissection and successfully resolved it.The patient status remained stable throughout the procedure.Additional information will be requested regarding this event.

Manufacturer Narrative

The oad was received with the original guide wire engaged in the device.The initial visual and tactile examination revealed that the saline sheath was deformed at the distal end of the sheath.The saline sheath was also twisted in this area, indicating that the device was spun while the crown was lodged within the saline sheath.Examination of the crown and distal tip bushing revealed that they remained intact and undamaged.Biological material was observed within the saline sheath and on the crown.Further examination revealed that the saline sheath was damaged and separated 93.2cm distal to the nose cone assembly.The driveshaft exhibited some deformed and fractured filars 108cm distal to the lap weld.Examination also revealed damage to the inner diameter (id) of the saline sheath, possibly from the fractured driveshaft filar spinning inside.The outside diameter (od) of the driveshaft and crown were measured using a calibrated dial caliper and met the drawing specification.The placement of the crown also met the drawing specifications.The driveshaft was analyzed using a scanning electron microscope (sem).Sem analysis identified the presence of fatigue on the fractured filars.This damage is consistent with a localized elevated stress level applied to the driveshaft while spinning.The initial visual and tactile examination of the exposed sections of the guide wire revealed that the distal section had two kinks in the shaft.Further examination revealed that the spring tip and distal and proximal solder bonds remained intact and undamaged.No biological material was observed on the shaft or spring tip.The guide wire was destructively removed from the handle assembly.Examination of the remaining section of the guide wire did not reveal any additional damage that would have contributed to the difficulties experienced during the procedure.The damaged driveshaft and saline sheath were destructively cut just proximally from the damaged filars to allow for functional testing.An in-house 0.014" guide wire was then loaded through the remaining driveshaft and handle assembly without issue.When tested, the oad 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.At the conclusion of the failure analysis investigation, the root cause of the dissection could not be determined.The root cause of the oad getting stuck on the guide wire could not be conclusively determined.(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: 5554254
• MDR Text Key: 42062701
• Report Number: 3004742232-2016-00033
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133399
• 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: 04/07/2016

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: 10/31/2017
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: PRD-SC30-200
• Device Lot Number: 113715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 04/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2014
• 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
• Patient Age: 78 YR