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

Model Number DBEC-125

Device Problem Insufficient Information (3190)

Patient Problem Vascular Dissection (3160)

Event Date 05/26/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The diamondback 360® coronary orbital atherectomy system instructions for use manual states that vessel dissection is a potential adverse event that may occur and/or require intervention with use of the system.Device evaluation conclusion: the oad and saline pump were returned to csi for analysis.Visual examination did not reveal any damage.The oad operated as intended during functional testing.However, the device data log revealed a power loss event.The failure could not be replicated during analysis.It is possible the returned pump had an intermittent issue; however, this could not be confirmed through analysis.The root cause of the power loss remains undetermined.Regarding the reported dissection, there were no observed damage or abnormalities that would have contributed to it.As the guidewire was not returned for analysis, it could not be determined if it was damaged or contributed to the reported events.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).

Event Description

The diamondback coronary orbital atherectomy device (oad) repeatedly stopped spinning during use in the proximal left anterior descending artery (lad).The oad had not been tested prior to use in the patient, and the physician had ballooned with poba and a cutting balloon prior to using the oad.Imaging revealed a vessel dissection, which was treated with a two-minute balloon inflation.The patient was then scheduled for bypass surgery due to remaining disease and inability to treat the lad.

• Brand Name: DIAMONDBACK 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: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 12041194
• MDR Text Key: 257463473
• Report Number: 3004742232-2021-00225
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491356
• UDI-Public: (01)10850000491356(17)230228(10)368795-1
• 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: 06/22/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-01
• Device Lot Number: 368795-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2021
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 103