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

Model Number	DBEC-125
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	02/12/2021
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.Csi id# (b)(4).
Event or Problem Description
Treatment was planned for a 99.9% stenosed lesion located in the tortuous mid-right coronary artery.The lesion was pre-dilated with balloon angioplasty and plaque rupture was observed on imaging.A microcatheter and balloon were unable to pass the lesion for additional treatment.As the viperwire guide wire had passed the lesion, diamondback coronary orbital atherectomy device (oad) was selected for treatment.On the second treatment pass tissue wrap of the subintimal plane occurred, and the oad became stuck in the vessel.All devices were removed from the patient, and a perforation occurred.Unsuccessful attempts were made to rewire the lesion for 2 hours, and the perforation was left untreated.It was observed that flow had been restored distally, and the patient was transferred to the intensive care unit.The patient was stable and discharged home on (b)(6) 2021 with no additional angiography.

• 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; saint paul MN 55112
• MDR Report Key: 11348085
• Report Number: 3004742232-2021-00053
• Device Sequence Number: 11599039
• Product Code: MCX
• UDI-Device Identifier: 10852528005787
• UDI-Public: (01)10852528005787(17)220228(10)311865
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-13
• Device Lot Number: 311865
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 02/19/2021
• 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: Hospitalization
• Patient Age: 73 YR
• Patient Weight: 56