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

Model Number	DBEC-125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	08/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.The diamondback coronary orbital atherectomy system instructions for use manual states that perforation is a potential adverse event that may occur and/or require intervention.Csi id: (b)(4).
Event or Problem Description
During treatment of a calcified lesion in the proximal left anterior descending artery, the viperwire guide wire was not placed as distally in the vessel as desired.Following three treatment passes on low speed with a diamondback coronary orbital atherectomy device (oad), the oad was removed in order to prevent operation too close to the guide wire spring tip.Balloon angioplasty was performed, but the balloon would not traverse distally.A guide catheter was used to enable another balloon to reach the distal location, and after multiple inflations the balloon burst.It was determined that additional atherectomy treatment was required to facilitate stent placement, and the physician declined to use ivus.The guide wire was removed and no dissection was noted angiographically.Glideassist was used to advance the oad beyond the area treated with angioplasty and 6-7 additional treatment passes were performed until no resistance was felt.Following the final treatment pass, imaging was performed and a contained perforation was observed.The perforation was resolved with stent placements and the procedure was continued with the patient in stable condition.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• MDR Report Key: 12355651
• Report Number: 3004742232-2021-00298
• Device Sequence Number: 4418049
• Product Code: MCX
• UDI-Device Identifier: 10850000491356
• UDI-Public: (01)10850000491356(17)221231(10)358708-1
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/23/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-01
• Device Lot Number: 358708-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 08/23/2021
• 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