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

Model Number DBEC-125

Device Problem Entrapment of Device (1212)

Patient Problems Vascular System (Circulation), Impaired (2572); Vascular Dissection (3160)

Event Date 07/23/2020

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.(b)(4).

Event Description

A diamondback coronary orbital atherectomy device (oad) was selected for treatment via right radial access in the lad after previous, failed pci.One lesion was treated and stented without issue.Wire exchange was then performed for placement in the obtuse marginal (om) artery, which was very tortuous.The oad was advanced to the circumflex (cx) artery, and glideassist was used to advance the crown to the lesion.Placement was verified, and treatment was begun on low speed.While the device was reaching speed, the device lost speed and stalled.The physician attempted to start the device again, but the issue recurred.The oad then appeared to be stuck in the vessel; it could not be retracted.Angiography showed good flow in the om and decreased flow in the cx.A dissection was identified.An additional attempt was made using glideassist to remove the device from the lesion.The oad again stalled, and the oad was stuck on the wire.A non-csi wire was advanced to the area to maintain wire position, and the oad and viperwire were removed from the patient.Angioplasty was then performed in the om.Flow returned to the cx.Post dilation angiography showed good flow in the om.The cx and om were then stented.The patient did not experience changes in hemodynamics or rhythm.In the opinion of the physician, the cause of the adverse event was tortuosity of the om.

Manufacturer Narrative

Device analysis conclusion: the oad and guide wire were received at csi for analysis.The guidewire was engaged in the oad.Visual examination revealed dried, adhered, biological material on the driveshaft and crown.Examination of the driveshaft and crown did not reveal any damage that would have contributed to the material accumulation.There was significant resistance felt in the area of the adhered material when an attempt was made to remove the guidewire.The device data was downloaded and showed numerous stall conditions.The oad operated as intended during functional testing.At the conclusion of the device analysis investigation, the reported stalling of the oad and the report that the oad became stuck on the wire were confirmed.Adhered biological material seems to have contributed to these reported events; however, the root causes of these events could not be determined.The reported events concerning the wire becoming stuck in the vessel and dissection could not be confirmed through analysis.The root cause of these reported events could not be determined.Csi id: (b)(4).

• 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
• MDR Report Key: 10437866
• MDR Text Key: 203882686
• Report Number: 3004742232-2020-00255
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491356
• UDI-Public: (01)10850000491356(17)220331(10)320033
• Combination Product (y/n): N
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

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: 03/31/2022
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-01
• Device Lot Number: 320033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2020
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 08/25/2020
• Supplement Dates FDA Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 109