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

Model Number DBEC-125

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/19/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.A final report will be submitted once the investigation is completed.Related regulatory report 3004742232-2024-00081.Csi id: (b)(4).

Event Description

Following a wire exchange for the viperwire advance guide wire the diamondback 360 coronary orbital atherectomy device (oad) was used for treatment in a 4mm, 90% stenosed, highly tortuous left circumflex artery (lcx).The oad was advanced on glideassist and then spun three times on low speed and three times on high speed.Cineangiography was checked and the oad driveshaft was fractured distal to the crown.The oad was removed and after five hours, the fractured component was successfully retrieved with a guide extension catheter.A new oad and same viperwire were used to resume atherectomy, treating with the pushing and pulling technique.The viperwire was observed to be moving abnormally.The oad was stopped.When attempting to pull on the viperwire, it could not be extracted, and it was observed to be fractured.Unsuccessful attempts were made to retrieve the fractured viperwire component.A stent was placed to pressure bond the fractured component and the procedure was completed.The patient was stable.

Manufacturer Narrative

The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.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 hwy 8 nw; st. paul
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: poonoy chanthavongsa ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 18527718
• MDR Text Key: 333049933
• Report Number: 3004742232-2024-00080
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491530
• UDI-Public: (01)10850000491530(17)240731(10)441099-1
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

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 Expiration Date: 07/31/2024
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-05
• Device Lot Number: 441099-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/11/2022
• 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
• Patient Outcome(s): Required Intervention