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

Model Number DBEC-125

Device Problem Air/Gas in Device (4062)

Patient Problems Air Embolism (1697); Atrial Fibrillation (1729)

Event Date 04/29/2021

Event Type  Injury  

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.The diamondback coronary orbital atherectomy system instructions for use manual states that air must be purged from the oad to ensure that there are no air bubbles within the saline tubing, and to use standard hospital procedures to aspirate or purge air from the lines.Aspiration should not be attempted while placed within the patient's body.An air embolism is a potential adverse event that may occur and/or require intervention.(b)(4).

Event Description

The diamondback coronary orbital atherectomy device (oad) was activated for priming, however priming was stopped by the technician.A stopcock had been placed in-between the device saline port and saline spike line, therefore the oad was not fully primed.The oad was inadvertently inserted into the patient without noticing this.The oas pump was powered on, glideassist mode was activated and a large air embolism was observed during fluoroscopy.The patient went into atrial fibrillation, which resolved after a few minutes without additional intervention.Treatment in the left anterior descending artery was performed with good results and no additional issues.The patient was transferred to the hospital for observation and discharged the following day.Per the physician, the atrial fibrillation was caused by the air embolism, from the air in the saline line.

• 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; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: brittany leider ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 11886327
• MDR Text Key: 254044916
• Report Number: 3004742232-2021-00187
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491356
• UDI-Public: (01)10850000491356(17)230228(10)369001-1
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2021

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: 02/28/2023
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-01
• Device Lot Number: 369001-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• 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): Life Threatening
• Patient Age: 78 YR
• Patient Weight: 78