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

Model Number DBEC-125

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2022

Event Type  malfunction  

Manufacturer Narrative

Return of the device for analysis is anticipated.If the device is received for analysis, a supplemental report will be submitted when the device analysis is completed.Csi id: (b)(4).

Event Description

After the diamondback 360 coronary orbital atherectomy device (oad) was advanced into the guide catheter, excessive leaking was observed.In addition, glideassist could not be activated.A second oad was used to complete the procedure.

Manufacturer Narrative

The oad was returned to csi for analysis.There were no abnormalities or damage observed with the driveshaft or handle assembly.During a fluid flow test, no leaks were observed and flow measurements were as expected.During a functional test of the oad, the driveshaft was not spinning.Analysis revealed the guide wire hypotube support to be detached allowing the output gear to become disengaged from the motor gear.When the output gear was re-engaged and the guide wire hypotube support was re-attached, the device functioned as intended.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 hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: aaron stevens ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 15641810
• MDR Text Key: 306835299
• Report Number: 3004742232-2022-00243
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)240331(10)425019-1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

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: 03/31/2024
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-09
• Device Lot Number: 425019-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/20/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2022
• 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