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

Model Number DBEC-125

Device Problem Mechanical Jam (2983)

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

Event Date 09/29/2022

Event Type  malfunction  

Manufacturer Narrative

The oad was returned to csi for analysis which identified the presence of material within the driveshaft of the oad.The material prevented the passage of the viperwire through the oad.The root cause of the observed material is under investigation.Csi will submit a supplemental report once the investigation is complete.Csi id: (b)(4).

Event Description

During an attempt to pass a viperwire advance guide wire through a diamondback 360 coronary orbital atherectomy device (oad), the viperwire could not pass through the oad.The viperwire appeared to stop at the brake area of the oad.No damage was observed on the viperwire or the oad.The oad was exchanged for a second oad, which was used for the procedure with the same viperwire.The oad which did not allow for viperwire passage was returned to csi for analysis which identified the presence of material within the driveshaft.

Manufacturer Narrative

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.Following oad analysis, csi performed analysis and investigation related to the production of the device.During this investigation, attempts were made to create the event of foreign particulate in the oad driveshaft but were unsuccessful.A review of manufacturing processes and final functional tests could not identify how the event could have occurred during the manufacturing of the device.Therefore, the cause of the reported event could not be conclusively determined.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: sadie martin ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 16077556
• MDR Text Key: 308477385
• Report Number: 3004742232-2022-00305
• Device Sequence Number: 1
• Product Code: MCX
• 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: 04/05/2022

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: 425092-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 04/05/2023
• 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