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

Model Number	DBP-EX-200SOL145
Medical Device Problem Codes	Entrapment of Device (1212); Mechanical Problem (1384)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported oad was received for analysis.Adhered biological material was observed on the driveshaft and crown.Examination of the area of area adhered material did not reveal any damage that would have contributed to the accumulation.The morphology and exact root cause of the accumulation is unknown.The driveshaft was stretched proximal to the crown.A guide wire met resistance at the area of adhered material.Adhered biological material was found within the driveshaft filars.The driveshaft was cut, and the guide wire passed through the remaining driveshaft and handle assembly with no resistance.When tested, the oad spun on all speeds and functioned as intended.Device data logs revealed some stall conditions, however, this could not be replicated during analysis.At the conclusion of the device analysis the reported events of a device stall and tissue on the crown was confirmed.The oad becoming stuck in the sheath, vessel spasms, and thrombus were unable to be conclusively confirmed through analysis.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.(b)(4).
Event or Problem Description
During a peripheral procedure, the peripheral exchangeable orbital atherectomy device (oad) was used to treat a chronic total occlusion (cto) of the superficial femoral artery (sfa).The lesion was 120 mm in length with 100% stenosis and 90% calcification, and the vessel was 6mm in diameter.After 2 treatments on low speed, one treatment on medium speed, and two treatments on high speed, the oad seemed to stall and could not be pulled back into the sheath.Vessel spasms occurred and were treated with nitroglycerin.The device was pulled with considerable force to be pulled back into the 6fr sheath.Tissue and debris were noted on the oad crown.Clots began forming in the vessel, and the clots were removed.The procedure was completed with balloon angioplasty and stent placement.In the opinion of the physician, the clots were located within the cto lesion when the lesion was treated with orbital atherectomy, and the clots were caused by the patient's clotting disorder.It was reported that the patient was heparinized with 3000 units of heparin.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 10706507
• Report Number: 3004742232-2020-00323
• Device Sequence Number: 17015015
• Product Code: MCW
• UDI-Device Identifier: 10852528005848
• UDI-Public: (01)10852528005848(17)220831(10)340544
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/20/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: DBP-EX-200SOL145
• Device Catalogue Number: 7-10030-04
• Device Lot Number: 340544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 91