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

Model Number DBEC-125

Device Problem Material Separation (1562)

Patient Problems Chest Pain (1776); High Blood Pressure/ Hypertension (1908); Foreign Body In Patient (2687)

Event Date 04/14/2021

Event Type  Injury  

Manufacturer Narrative

Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Csi id: (b)(4).

Event Description

The target lesions were severely calcified and located in the tortuous mid circumflex and proximal obtuse marginal arteries.Eight treatment passes were performed on low speed with the diamondback coronary orbital atherectomy device (oad) without complications, and the patient remained stable.The crown of the oad was observed to jump during pullback of the final treatment pass, and a cine showed that the vessel was intact.Glideassist mode was activated, however the oad shut off while being removed.When the tip of the oad was removed from the guide catheter, it was observed that the crown and tip bushing had detached.As there were no available snare devices, other troubleshooting techniques were utilized in attempts to remove the device fragment, including attempts to remove the viperwire guide wire simultaneously with the fragment.This was unsuccessful, as were multiple attempts to re-wire the vessel.The oad fragment remained embedded in the subintimal layer of the circumflex.The patient presented with chest pain and hypertension and was stabilized prior to leaving the procedure room.The patient was discharged the following day.

Manufacturer Narrative

The oad was received at csi for analysis.A visual examination confirmed a fracture in the driveshaft located at the proximal edge of the driveshaft crown.The distal driveshaft crown section was not returned for analysis.Driveshaft flexing at the weld location can initiate a fatigue failure.Scanning electron microscopy analysis identified fatigue striations at the site of the driveshaft fracture.It is hypothesized that this driveshaft underwent excessive flexing near the crown due to spinning in excessive tortuosity or resistance that pushed the driveshaft into a tight bend shape, although the exact root cause of this reported fracture is undetermined.The instructions for use for the coronary oas state the following warning, "never force the crown if any resistance is felt within the vessel as vessel perforation may occur.If resistance is felt, retract the crown, while monitoring the cause of the resistance, and immediately stop treatment.Use fluoroscopy to analyze the situation and to monitor the cause of the resistance." 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 prior to distribution.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 MN 55112
• MDR Report Key: 11802508
• MDR Text Key: 257159131
• Report Number: 3004742232-2021-00169
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491417
• UDI-Public: (01)10850000491417(17)230228(10)368105-1
• Combination Product (y/n): N
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/19/2021

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 Lot Number: 368105-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 05/10/2021
• Supplement Dates Manufacturer Received: 05/10/2021
• Supplement Dates FDA Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 70