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

Model Number DBEC-125

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2019

Event Type  malfunction  

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

During set-up for a procedure, the saline line of the diamondback coronary orbital atherectomy device (oad) was unable to be flushed of air.Attempts were made to flush the oad using the prime button and a syringe, but the attempts were unsuccessful.A second oad was used for the procedure.The procedure was completed with no patient complications.

Manufacturer Narrative

The reported oad with the saline line was received for analysis.It was observed that the saline line luer connector was fractured at the proximal edge of the y-adaptor.The exact cause of the damage was unable to be determined.Additional testing for purging the device of air bubbles was unable to be performed due to the fracture.There was no other damage observed to the device that would have contributed to the event.The oad was tested and the device spun at both speeds with no abnormalities observed.At the end of the device analysis investigation, the reported event of being unable to flush the saline tubing of air was unable to be confirmed as additional testing was unable to be done due to the fracture.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.Csi id# (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 8486413
• MDR Text Key: 141018192
• Report Number: 3004742232-2019-00098
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005428
• UDI-Public: (01)10852528005428(17)200930(10)241105
• 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: 04/25/2019

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: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-12
• Device Lot Number: 241105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 04/05/2019
• Supplement Dates Manufacturer Received: 04/19/2019
• Supplement Dates FDA Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1