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

Model Number DBEC-125

Device Problem Unintended System Motion (1430)

Patient Problem Great Vessel Perforation (2152)

Event Date 05/02/2023

Event Type  Injury  

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.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.H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for user manual states that a perforation of vessels is a potential adverse event that may occur and/or require intervention with use of the system.Csi id: (b)(4).

Event Description

During treatment of a tortuous, highly calcified left anterior descending artery with a diamondback 360 coronary orbital atherectomy device (oad), the oad stalled.The oad was being removed, and the oad began to spin.Difficulty was experienced to cross the lesion.During the attempt to cross the lesion with extra force, the oad crown jumped forward.Angiographic imaging confirmed a perforation at the primary lesion location.Balloon tamponade and stent placement were performed.Another angiogram was performed and a severe perforation was observed at the proximal lesion.Stent placement was performed to resolve the perforation.The patient was admitted to the intensive care unit for observation.The patient was stable and discharged.

• 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: tonia moskalets ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 17052876
• MDR Text Key: 316471142
• Report Number: 3004742232-2023-00155
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)240531(10)435913-1
• 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
• Report Date: 06/02/2023

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: 05/31/2024
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-09
• Device Lot Number: 435913-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• 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; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White