MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY DEVICE

Model Number SIP-3000

Device Problem Improper Flow or Infusion (2954)

Patient Problems Non specific EKG/ECG Changes (1817); Patient Problem/Medical Problem (2688)

Event Date 10/11/2018

Event Type  Injury  

Manufacturer Narrative

Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.(b)(4).

Event Description

The stealth saline infusion pump flow rate seemed abnormal at the start of the atherectomy procedure.Immediately upon start of atherectomy treatment, t-wave inversion and st segment elevations were noted and the patient coughed violently.The prime button was pressed, but the resulting priming speed seemed to accelerate to about 80ml per minute as opposed to the usual 40ml per minute rate.The device was removed from the patient and a competitor product was used to complete the procedure.Upon removal of the device from the patient, the physician noted that the flow rate seemed much faster than usual.The patient was well following the procedure.Reportedly, the device had not been tested ex vivo during set up.

Manufacturer Narrative

At the conclusion of the failure analysis investigation the reported event could not be confirmed.The saline pump motor was tested for functionality and run for a total run time of 45 minutes at high speed without any issues.The pump saline flow rates were within specification when tested with the returned saline line with and without an oad.It should be noted that the original oad could not be tested with the saline pump due to the shipping damage observed on the oad upon receipt.An in-house similar model oad was used for testing.The in-house oad was tested with the saline pump and spun on both speeds low and at high 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.(b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 8048571
• MDR Text Key: 126504624
• Report Number: 3004742232-2018-00330
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/13/2018

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: Health Professional
• Device Model Number: SIP-3000
• Device Catalogue Number: 70057-03
• Device Lot Number: 188878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 11/07/2018
• Supplement Dates Manufacturer Received: 11/09/2018
• Supplement Dates FDA Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other