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

Model Number DBEC-125

Device Problem Entrapment of Device (1212)

Patient Problems Perforation of Vessels (2135); Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)

Event Date 02/27/2024

Event Type  Death  

Event Description

The patient was staged to undergo percutaneous coronary intervention (pci) and the viperwire advance guidewire was inserted into the left main coronary artery.Left main artery was short about 3-5 mm with an acute turn into an ostial circumflex and there was a calcific nodule at the ostial circumflex.The physician advanced diamondback 360 coronary orbital atherectomy device (oad) in antegrade motion and came back retrograde and then rested.After resting, the physician advanced the oad in antegrade motion again, however, the oad stalled and could not move and was stuck.When the oad was pulled back, the crown jumped and the oad and guidewire pulled out of the vessel.A contrast was injected to see the vessel, following which perforation and dissection at the circumflex, left anterior descending (lad) artery and left main aorta were observed.The patient was coded for 40 minutes, and then expired.In the physician's opinion, the oad caused patient's death.

Manufacturer Narrative

The device history record for the reported oad could not be reviewed as the lot number was not provided.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 use manual states that a perforation of vessels and dissection are potential adverse events that may occur and/or require intervention with use of the system.Csi id: (b)(4).

Manufacturer Narrative

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; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INC.; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer Contact: keerthi bangalore ramanath ; 1225 old highway 8 nw; st. paul, MN 55112
• MDR Report Key: 18978010
• MDR Text Key: 338589953
• Report Number: 3004742232-2024-00142
• 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: 04/12/2024

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 Model Number: DBEC-125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: No
• 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; Other; Death
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Race: White