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

Model Number DBP-200SOLID145

Device Problem Mechanical Problem (1384)

Patient Problem Perforation of Vessels (2135)

Event Date 08/26/2020

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.Csi id: (b)(4).

Event Description

Orbital atherectomy (oa) was performed on low, medium and high speed in the heavily calcified common femoral and external right iliac arteries.During the high speed treatment pass, the diamondback peripheral orbital atherectomy device (oad) stalled.The control knob was moved approximately one to two cm, and the oad was removed.A small amount of tissue was observed on the oad.Imaging was performed and revealed a vessel perforation distal to the internal iliac artery.One two-minute balloon inflation was performed, after which no extravasation was present.Stents were placed in the common iliac and internal iliac.Imaging did not show any additional bleeding.The patient remained stable throughout the procedure and was kept overnight for observation.In the opinion of the physician, there was no allegation of malfunction against the oad.A dissection may have been present prior to oa treatment, and the oad may have been subintimal during treatment; however, the cause of the perforation was unknown.

Manufacturer Narrative

The reported oad was received at csi for analysis.Visual examination revealed adhered biological material on the driveshaft.Examination of the area of adhered material did not reveal any damage that would have contributed to the accumulation.A data download of the device revealed a stall event.The perforation could not be confirmed through analysis.When tested, the oad functioned as intended.At the conclusion of the device analysis, the report that the oad stalled and a perforation occurred could not be confirmed through analysis, however it was confirmed that tissue was present on the driveshaft.It was hypothesized that the accumulated biological material may have contributed to the perforation, stall and tissue observed on the driveshaft events.The morphology and exact root cause of the accumulation is unknown.The 360 diamondback peripheral orbital atherectomy device instructions states that a perforation may occur or require intervention as a result of the use of this device.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.H6: results code: 4247 -suggested code is biological material present on device.Csi: (b)(4).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 10577153
• MDR Text Key: 208311904
• Report Number: 3004742232-2020-00283
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491202
• UDI-Public: (01)10850000491202(17)220531(10)328768
• Combination Product (y/n): N
• PMA/PMN Number: K190634
• 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: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: 7-10057-04
• Device Lot Number: 328768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 58