MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED STEALTH 360 ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY SALINE INFUSION PUMP

Model Number SIP-3000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2014

Event Type  malfunction  

Event Description

It was reported that during a peripheral orbital atherectomy procedure, a csi saline infusion pump malfunctioned and the csi orbital atherectomy system could not be used.The physician had successfully treated two lesions in the superficial femoral artery (sfa) with a csi orbital atherectomy device (oad).During treatment of the third lesion in the popliteal artery, when the pump transitioned from high flow rate to low flow rate, it switched to stand-by.The physician was unable to complete treatment using the csi device and completed the intervention by placing an unplanned stent.Three requests for additional information have been made, but none has been received.

Manufacturer Narrative

Device analysis: the saline pump was returned with the original saline bag weight sensor and power cord.The original oad was not returned for analysis.The initial visual examination did not reveal any damage or abnormalities that would have contributed to the reported event.Further examination revealed the power cord to be intact and undamaged.The saline pump was plugged in and activated (powered on).The primer button was pressed and the pump increased to high speed as intended, then reverted back to slow speed and continued to run as intended.The pump motor was then tested using an in-house test fixture that simulates the electrical load of an orbital atherectomy device (oad).The high speed switch to the test fixture was turned on and the pump increased to high speed as intended.Once the test fixture was shut off (simulating turning off the oad) the motor reverted back to slow speed without any issues.The pump motor was then run at high speed for approximately fifteen minutes and retested after resting for one minute.The high speed switch to the test fixture was turned on and the pump increased to high speed and functioned as intended.Once the test fixture was shut off (simulating turning off the oad) the motor reverted back to slow speed and the pump switched to stand-by (indicated by a yellow led), rather than continuing to run at low speed.The pump motor was diagnostically tested and found to have a fast running pump motor.At the conclusion of the failure analysis investigation, the reported event was confirmed and the root cause isolated.The root cause of the reported event was an out of specification saline pump.Corrective actions have been implemented to address this issue.(b)(4).

• Brand Name: STEALTH 360 ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY SALINE INFUSION PUMP
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 651 campus drive; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED; 651 campus drive; saint paul MN 55112
• Manufacturer Contact: megan brandt ; 651 campus drive; saint paul, MN 55112 ; 6512592805
• MDR Report Key: 3984951
• MDR Text Key: 4815993
• Report Number: 3004742232-2014-00036
• 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: 07/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: SIP-3000
• Device Catalogue Number: SIP-3000
• Device Lot Number: 73713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2014
• Initial Date FDA Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention