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

Model Number PRD-SC30-200

Device Problem Difficult to Advance (2920)

Patient Problem Vascular Dissection (3160)

Event Date 04/27/2015

Event Type  Injury  

Event Description

It was reported that during a peripheral orbital atherectomy procedure, multiple dissections occurred while using a csi orbital atherectomy device (oad).Additionally, the physician noted difficulty advancing the oad through the introducer sheath, difficulty during treatment and difficulty when removing the device after treatment.The target lesion was 30%-40% stenotic, 1cm in length and was located in the superficial femoral artery (sfa).The physician used a 6fr introducer sheath from a retrograde approach to access the lesion.The physician performed atherectomy using the csi oad, but when removing the oad, he noted that it was stuck on the guidewire.The physician removed the oad and guidewire as a unit.Post-atherectomy angiography revealed multiple dissections which were resolved with balloon angioplasty and stent placement.The patient status remained stable throughout the procedure.Three 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 or introducer sheath.The initial visual and tactile examination revealed axial compression damage of the saline sheath 14.0cm distal to the nosecone bond site.The damage extended 2.0cm distally.It should be noted that bench top testing in the failure analysis lab was able to replicate the failure by constraining the driveshaft and then pulling the control knob in a proximal direction.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 control knob was visually examined and no damage was observed.The control knob remained secure and intact.When the knob was moved distally or proximally, no resistance was met within the handle.An in-house 0.014" test wire was loaded through the handle assembly without resistance.When tested, the oad spun at low, medium and at high speed with no abnormalities observed.While the saline pump was running, the distal end of the saline sheath was restricted to pressurize the saline sheath and saline line.No holes or leaks were observed within the saline sheath or saline line.The device performed as intended.The driveshaft and saline sheath subassemblies were measured and met dimensional specifications.At the conclusion of the failure analysis investigation, the root cause of the difficulty advancing and retracting the device could not be determined.The root cause of the dissections also could not be determined.As the original introducer sheath and guidewire were not returned for analysis it could not be determined whether or not they were damaged or if they contributed to the difficulties experienced during the procedure.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: 4791794
• MDR Text Key: 5877157
• Report Number: 3004742232-2015-00032
• 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: 05/20/2015

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: 124093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2015
• Initial Date FDA Received: 05/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2015
• 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