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

Model Number SIP-3000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), a device malfunction occurred leading to a procedural delay.During device preparation, two oads would not spin prior to insertion into the patient.The saline pump was noted to be in standby mode and was determined to be the source of the issue.Troubleshooting was performed for 45 minutes, however the issue was not resolved and the procedure was completed with balloon angioplasty.There were no patient complications reported.

Manufacturer Narrative

The reported saline pump was received for analysis with two oads utilized during the procedure.When the saline pump was tested with the returned oads, it repeatedly defaulted to standby mode.The oads were tested with an in-house saline pump and were found to function as intended.The saline pump motor was diagnostically examined and was found to operate at a slower speed when in a cold state as opposed to a hot state, resulting in the pump entering standby mode.At the conclusion of the device analysis investigation, the reported event was confirmed.The device history record for this saline pump and oad lot numbers 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.Csi id# (b)(4).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 7732631
• MDR Text Key: 115472888
• Report Number: 3004742232-2018-00225
• Device Sequence Number: 1
• Product Code: MCW
• 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: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIP-3000
• Device Catalogue Number: 70057-03
• Device Lot Number: 187902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Date Manufacturer Received: 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1