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

Model Number	DBP-200SOLID145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Intraoperative Pain (2662); Vascular Dissection (3160)
Date of Event	08/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The diamondback 360 peripheral orbital atherectomy device (oad) was used to treat a calcified external iliac lesion, near chronic total occlusion (cto).The vessel anatomy was normal, not very tortuous nor were there tight curves.A treatment was performed on low-speed when the patient experienced pain.Angiography revealed no issues.In the opinion of the physician, the second treatment, which was performed on medium speed, led to a perforation of the vessel.The physician believed the oad became subintimal during the second treatment.Balloon angioplasty was used to control the perforation, and an upsized sheath was used to deliver a covered stent from the external iliac artery to the common iliac artery.A second stent was eventually placed, and another dissection occurred.During this intervention, the patient experienced hypotension, which was managed with medication.The patient required an additional surgery and remained hospitalized ten days post procedure in stable condition.
Additional Manufacturer Narrative
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.The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: 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: aaron stevens ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 15498479
• Report Number: 3004742232-2022-00229
• Device Sequence Number: 5070163
• Product Code: MCX
• UDI-Device Identifier: 10850000491202
• UDI-Public: (01)10850000491202(17)231031(10)406088-1
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: 7-10057-04
• Device Lot Number: 406088-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White